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Urological Clinical

Cancer Data Standards

June 2009

National Clinical Dataset Development Programme (NCDDP) Support Team Information Services Area 74A Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB Tel: 0131 275 7066 Email to: [email protected]: www.clinicaldatasets.scot.nhs.uk

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http://www.clinicaldatasets.scot.nhs.uk/

...............................................................................................4 Overview & BackgroundOverview...................................................................................................................4 Background to NCDDP.............................................................................................4 Clinical Terminology .................................................................................................5 Date Recording.........................................................................................................5

Section 1. Urological Cancer Core Data Standards.....................................................7 Generic Data Item Table 1 ........................................................................................7

Urological Cancer Data Standards...............................................................................9 Section 2. Generic Urological Cancer ........................................................................10

2.1 Chemotherapy Agent (Urological Cancer)........................................................10 2.2 Biological Agent (Urological Cancer)................................................................11 2.3 Hormonal Therapy............................................................................................12 2.4 Hormone Ablative Therapy Regimen ...............................................................14 2.5 Clinical Trial Name (Urological Cancer) ...........................................................15 2.6 Clinical Features...............................................................................................21 2.7 Bisphosphonate Agent .....................................................................................24 2.8 Radionuclide.....................................................................................................25 2.9 Adverse Outcomes ...........................................................................................26 2.10 Complications Timing .....................................................................................28 2.11 Surgical Procedure (Urological Cancer) .........................................................29 2.12 Laparoscopic Procedure Type........................................................................31 2.13 Surgical Procedure Access ............................................................................32 2.14 Laser Type......................................................................................................33 2.15 Vena Cava Exploration Type..........................................................................33 2.16 Prosthesis Status............................................................................................34 2.17 Prosthesis Offered..........................................................................................34 2.18 Reason for Scrotal Approach .........................................................................35 2.19 Type of Specimen (Urological Cancer)...........................................................35 2.20 Fistula Sites ....................................................................................................37 2.21 Serum Marker.................................................................................................37 2.22 Needle Core Site ............................................................................................38 2.23 Number of Needle Cores................................................................................39 2.24 Sentinel Lymph-node Dye Type .....................................................................39 2.25 Sentinel Lymph-node Dye Identified...............................................................40 2.26 Saphenous Vein Preserved............................................................................40 2.27 Number of Freeze Thaw Cycles .....................................................................40 2.28 Number of Cryo Needles ................................................................................41 2.29 Predisposing Factor(s) of Urological Cancer..................................................41 2.30 Tumour Appearance.......................................................................................42 2.31 Bladder Reconstruction Type .........................................................................43 2.32 Replacement Tissue.......................................................................................43

Section 3. Cancer of the Penis...................................................................................44 3.1 TNM Tumour Classification (Clinical) (Cancer of the Penis) ............................44 3.2 TNM Nodal Classification (Clinical) (Cancer of the Penis) ...............................44 3.3 TNM Metastases Classification (Clinical) (Cancer of the Penis) ......................45

Section 4. Cancer of the Prostate ..............................................................................46 4.1 TNM Tumour Classification (Clinical) (Cancer of the Prostate) ........................46 4.2 TNM Nodal Classification (Clinical) (Cancer of the Prostate) ...........................47 4.3 TNM Metastases Classification (Clinical) (Cancer of the Prostate) ..................47 4.4 Prostate Volume ...............................................................................................48 4.5 Prostate Specific Antigen (PSA) Assay ............................................................48 4.6 International Prostate Symptom Score (IPSS) .................................................49 4.7 International Prostate Symptom Score Bladder Emptying Sensation ..............50 4.8 International Prostate Symptom Score Re-Urination Within Two Hours ..........50 4.9 International Prostate Symptom Score Urination Hesitancy.............................51

Urological Cancer Data Standards

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4.10 International Prostate Symptom Score Urination Postponing Difficulty..........51 4.11 International Prostate Symptom Score Urinary Stream Strength ...................52 4.12 International Prostate Symptom Score Forced Urination ...............................52 4.13 International Prostate Symptom Score Number of Nocturia Episodes...........53 4.14 Quality of Life Due to Urinary Symptoms .......................................................53

Section 5. Cancer of the Testis ..................................................................................54 5.1 TNM Nodal Classification (Clinical) (Cancer of the Testis)...............................54 5.2 TNM Metastases Classification (Clinical) (Cancer of the Testis)......................54 5.3 Royal Marsden Hospital (RMH) Staging...........................................................55 5.4 International Germ Cell Consensus Classification (IGCCC) Prognostic Grouping.................................................................................................................56 5.5 S Category........................................................................................................57

Section 6. Cancer of the Kidney.................................................................................58 6.1 TNM Tumour Classification (Clinical) (Cancer of the Kidney) ..........................58 6.2 TNM Nodal Classification (Clinical) (Cancer of the Kidney) .............................59 6.3 TNM Metastases Classification (Clinical) (Cancer of the Kidney) ....................59 6.4 Leibovich Risk Category...................................................................................60 6.5 Memorial Sloan-Kettering Cancer Centre Prognosis Category ........................60

Section 7. Cancer of the Renal Pelvis and Ureter......................................................61 7.1 TNM Tumour Classification (Clinical) (Cancer of the Renal Pelvis and Ureter)................................................................................................................................61 7.2 TNM Nodal Classification (Clinical) (Cancer of the Renal Pelvis and Ureter) ..62 7.3 TNM Metastases Classification (Clinical) (Cancer of the Renal Pelvis and Ureter) ....................................................................................................................62

Section 8. Cancer of the Urinary Bladder...................................................................64 8.1 TNM Tumour Classification (Clinical) (Cancer of the Urinary Bladder) ............64 8.2 TNM Nodal Classification (Clinical) (Cancer of the Urinary Bladder) ...............65 8.3 TNM Metastases Classification (Clinical) (Cancer of the Urinary Bladder) ......65

Section 9. Cancer of the Urethra................................................................................67 9.1 TNM Tumour Classification (Clinical) (Cancer of the Urethra) .........................67 9.2 TNM Nodal Classification (Clinical) (Cancer of the Urethra) ............................67 9.3 TNM Metastases Classification (Clinical) (Cancer of the Urethra) ...................68

Section 10. Transitional Cell Cancer of the Prostate (Prostatic Urethra) ...................69 10.1 TNM Tumour Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra)) .................................................................................................69 10.2 TNM Nodal Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra)) .................................................................................................70 10.3 TNM Metastases Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra))...................................................................................70

Appendix 1 - Working Group......................................................................................72 Appendix 2 - Consultation Distribution List ................................................................73 Appendix 3 - Urological Cancer Proposed Changes..................................................74

Ablation Energy Source..........................................................................................74 Surgical Procedure Type (Colorectal Cancer)........................................................76 Type(s) of Continence Problem Identified (Bladder Continence) ...........................77 Treatment modalities {Cancer} ...............................................................................79 Chemotherapy Line Number ..................................................................................81


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Overview & Background

Overview

The Scottish Cancer Group supports the development of Urological Cancer Data Standards for NHS Scotland in order to ensure a national approach to the collection of clinical and non-clinical data items relating to cancer. The aim is to ensure inter-compatibility of national clinical information systems, and to support the implementation of an electronic integrated health record. Cancer already has a range of individual national data sets for audit, screening and registration and NCDDP standards build on these systems. National data standards will support data sharing and allow secondary use of data for these purposes. Some NCDDP cancer core standards and site-specific standards for breast, endometrial and head & neck cancers have already been published. However a need for further cancer urological standards was identified. A multi-disciplinary Clinical Working Group, established in May 2007 and supported by the National Clinical Dataset Development Programme (NCDDP) Support Team in Information Services Division (ISD), carried out the development of these urological cancer data standards.

The Urological Cancer Data Standards will: Define common data items recommended for collection in a wide variety of

clinical settings Support the exchange of patient information between healthcare providers Support the consistent recording of patient information throughout NHS

Scotland

It is important to emphasise that these are data standards rather than a dataset. This means that the individual data items included in this document are not required to be recorded together in a single clinical information system. However where it is considered appropriate to record a particular data item as part of the record of care, the information should be recorded in accordance with the nationally agreed standard.

Background to NCDDP

The National Clinical Dataset Development Programme (NCDDP) supports clinicians to develop sets of interoperable national datasets to facilitate the implementation of the integrated care records across NHS Scotland. These standards will: Support direct patient care, by reflecting current best practice guidance Facilitate effective communication between health care professionals Improve data quality and support secondary data requirements where possible

including data to support clinical governance Be freely and widely available through publication in the web-based Health &

Social Care Data Dictionary


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Incorporate agreed national clinical definitions and implement national terminology

Be UK compatible where possible

The Chief Medical Officer established the programme in 2003 to support clinicians developing national clinical data standards, initially to support the national priority areas. These standards are an essential element of the Electronic Health Record, a central aim of the National e-Health Strategy. More information can be found on our website www.show.scot.nhs.uk/clinicaldatasets/.

Clinical Terminology

The strategic standard for clinical terminology in NHS Scotland is SNOMED-Clinical Terms. This means that over the next few years, clinical information systems will progress to record clinical data using this international standard.

Date Recording

It is good record-keeping practice always to identify the date of recording of any clinical information. It is expected that all clinical information systems should include “date stamping” as standard functionality; therefore the Urological Cancer Standards do not deal with this issue. In many clinical situations, the date of an event, investigation, etc is required for clinical purposes and should be visible to the health care professional. This date may not be the same as the date on which the data are entered onto the system. In these instances the system must allow the health care professional to enter whichever date is appropriate. These issues must be addressed during system specification and development. The date format for storage and management within a system should conform to the 1Government Data Standards Catalogue format: CCYY-MM-DD. However, this does not preclude entry or display of data on the user interface using the traditional DD-MM-CCYY format. An example of a date & time in correct format is: 1997-07-16T19:20:30+01:00 (CCYY-MM-DDThh: mmTZD) It is recommended that a time should always be recorded with the appropriate date and not on its own, however it may not be necessary to display the date along with the time. This is of particular importance where any calculations or analyses are likely to be performed. Automated times recorded by IT systems should include all elements of the time, i.e. hour, minutes and seconds, and are expected to be actual. Where times are entered manually, it is likely that only the hours and minutes will be required, although in some circumstances only hours may be required. Time, or any element of the time (hours, minutes or seconds) may be actual or estimated. In some circumstances only an actual time may be acceptable, whilst in others an estimated time may be allowed. In the latter situation, it may be necessary to identify whether the time recorded is actual or estimated. Times identified as actual may be used in calculations and analyses. Times marked as estimated should be treated with caution and the implications of undertaking any calculations or analyses should be considered in the particular context within which the time is recorded or to be made subsequent use of. Where an estimated time is allowed, the appropriate degree of verification detail required should be decided, again dependent on the context in which it is recorded and how the time is to be used.


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http://www.show.scot.nhs.uk/clinicaldatasets/

Government Data Standards Catalogue 1. All times must be expressed in the 24 hour clock format, e.g. one minute past midnight is 00:01:00. 2. Values of any element less than 10 should be entered with a zero in the first position. 3. All times for UK transactions/events will be assumed to be GMT. 4. Systems should record whether the time is Coordinated Universal Time or British Summer Time in the “Time zone designator”. This will allow time elapsed to be calculated correctly, for example for A&E waiting times


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Section 1. Urological Cancer Core Data Standards

Generic Data Item Table 1

Previously Published Generic Standards Person Family Name Procedure (Clinical Imaging) Person Given Name Referred to Clinical Genetics Service Person Birth Date Date Histo/Cytopathological specimen taken Person Sex at Birth Histo/Cytopathology report number Location Code Histo/Cytopathology investigation report date Health Record Identifier Presentation Type CHI Number Antibiotic Prophylaxis (Pre-operative) Associated Professional Surgical Procedure Intent ASA Status Participant in Clinical Trial Discussed by Care Team Clinical Trial Formal Entry Date Reason not Discussed by Care Team Date of Clinical Status Assessment Route of Administration Person Death Date Imaging Modality Underlying Cause of Death Contrast Agent Administered Status

Previously Published Cancer Standards Date of Referral {Cancer} Reason Treatment Not Delivered {Cancer} Referral Source {Cancer} Date of Surgery {Cancer} Urgency of Referral {Cancer} Associated Professional Grade (Most Senior

Operating Surgeon) {Cancer} Date Referral Received {Cancer} Date Treatment Started {Cancer} Family History of Cancer {Cancer} Date Treatment Completed {Cancer} Date First Seen by Associated Professional {Cancer}

External Beam Radiotherapy Course Type {Cancer}

Site of Origin of Primary tumour {Cancer} Anatomical Treatment Site {Cancer} Tumour Type (Morphology of Tumour) {Cancer}

External Beam Radiotherapy Dose: Total Planned {Cancer}

Most Valid Basis of Diagnosis {Cancer} External Beam Radiotherapy Dose: Total Administered {Cancer}

Date of Diagnosis {Cancer} External Beam Radiotherapy Fractions: Total Planned {Cancer}

Synchronous Tumour Indicator {Cancer} External Beam Radiotherapy Fractions: Total Administered {Cancer}

Anatomical Imaging Site {Cancer} Chemotherapy Type {Cancer} Date of Imaging {Cancer} Chemotherapy Course Number {Cancer} Imaging Results {Cancer} Biological Therapy Type {Cancer} Date Discussed by Care Team {Cancer} Recurrence Indicator (Cancer) Seen by Specialist Palliative Care {Cancer} Primary Tumour Status {Cancer} Date First Seen by Specialist Palliative Care {Cancer}

Nodal Status {Cancer}

Reason Not Seen by Specialist Palliative Care {Cancer}

Metastatic Status {Cancer}

Type of First Treatment {Cancer} Date Recurrence First Suspected {Cancer}


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Date of First Treatment {Cancer} Date of Cancer Proven Recurrence {Cancer} Reason(s) for Delay in Starting First Treatment {Cancer}

Treatment Related Morbidity

Treatment Status {Cancer} 1 All data items in the table above are existing nationally approved data standards, which can be found in the Health and Social Care Data Dictionary.


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Urological Cancer Data Standards Data standards which are relevant to all patients and are used across specialties, disciplines and settings have already been developed by other clinical working groups and approved as national data standards for NHS Scotland. The full detail of these existing standards are published on the web-based Health and Social Care Data Dictionary .


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http://www.datadictionaryadmin.scot.nhs.uk/isddd/9215.html

http://www.datadictionaryadmin.scot.nhs.uk/isddd/9215.html

Section 2. Generic Urological Cancer

2.1 Chemotherapy Agent (Urological Cancer)

Definition: The type of cytotoxic agent used either alone or in combination to treat urological cancer. Format: Characters Field length: 2 Codes and values: Code Value 01 Bleomycin 02 Etoposide 03 Cisplatin 04 Methotrexate 05 Vinblastine 06 Mitoxantrone 07 Dactinomycin 08 Cyclophosphamide 09 Paclitaxel 10 Ifosfamide 11 Gemcitabine 12 Docetaxel 13 Mitomycin 14 Doxorubicin 15 Vincristine 16 Actinomycin 17 Carboplatin 18 Epirubicin 19 5-fluorouracil cream (5FU) 96 Not applicable 98 Other (specify) 99 Not known

Related data items: Chemotherapy Type {Cancer} Chemotherapy Total Number of Cycles Administered {Cancer} Chemotherapy Total Number of Cycles Planned Chemotherapy Course Completed As Planned Chemotherapy Cycle Frequency Reason for Not Completing Planned Treatment Course Route of Administration Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.2 Biological Agent (Urological Cancer)

Definition: The type of biological agent administered for the treatment of urological cancer. Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 01 Interferon alpha (IFN) 02 Aldesleukin Recombinant interleukin (IL-2) 03 Bacillus Calmette-Guérin (BCG)

04 Sorafenib 05 Sunitinib 06 Temsirolimus 07 Bevacizumab 08 Everolimus 96 Not applicable 98 Other (specify) 99 Not known

Related data items: Route of Administration Further Information: Biological agents include immunological agents and biological response modifiers. This list of agents is not a static list but represents an evolving list that will be reviewed according to NCDDP schedule for data standards review. Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.3 Hormonal Therapy

Main source of standard: The National Audit Cancer Datasets developed by the regional Cancer Networks supported by Information Services. Definition: The type of hormonal therapy delivered. Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value

A Buserelin B Goserelin C Leuprorelin D Triptorelin

01

Gonadorelin Agonist (GnRH)

Z Other (specify) 02 Gonadorelin

Antagonist A Degarelix A Cyproterone B Flutamide C Bicalutamide

03 Anti-androgen

Z Other (specify)

A Stilboestrol/

Diethylstilbestrol B Ethinylestradiol

(Ethinyloestradiol)

04 Oestrogens

Z Other (specify) 05 Anti-

oestrogens A Tamoxifen A Medroxyprogesterone B Megestrol

06 Progestogens

Z Other (specify) 07 Orchidectomy

A Dutasteride B Finasteride

08 5 alpha reductase inhibitor

Z Other (specify) A Prednisolone B Dexamethasone

09 Corticsteroid

Z Other (specify) 96 Not applicable 98 Other (specify) 99 Not known Related data items: Hormone Therapy Type {Cancer} Route of Administration


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Further Information: This list of agents is not a static list but represents an evolving list that will be reviewed according to NCDDP schedule for data standards review. Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ and sub-codes ‘Z - Other (specify)’ with a free text field for recording other values of this item.


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2.4 Hormone Ablative Therapy Regimen

Main source of standard: The National Audit Cancer Datasets developed by the regional Cancer Networks supported by Information Services. Definition: The pattern of hormone ablative therapy. Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 01 Maximal androgen blockade Primary MAB 02 Monotherapy 03 Combination 04 Antiandrogen Withdrawal 96 Not applicable 98 Other (specify) 99 Not known

Attributes: Combination type Combination to prevent tumour flare Combination for disease progression, Secondary MAB Related data items: Hormone Therapy Type {Cancer} Chemotherapy Line Number Reason for Not Completing Planned Treatment Course Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.5 Clinical Trial Name (Urological Cancer)

Main source of standard: National Cancer Research Network Cancer Clinical Studies Groups. Definition: The name of the clinical trial into which the patient was formally entered. Format: Characters Field length: 3 Codes and values: Code Value Explanatory Notes 01 ADVICE Study A Feasibility study of molecular markers in patients

with muscle invasive transitional cell carcinoma of the bladder entered into Neo-adjuvant chemotherapy trial.

02 BCPP Bladder Cancer Prognosis Programme. 03 BOXIT (Bladder COX-2

Inhibition Trial) BOXIT. IRSTCN 84681538

04 EORTC 30994 Randomized phase III trial comparing immediate versus deferred chemotherapy after radical cystectomy in patients with pT3-pT4, and/or N+M0 transitional cell carcinoma (TCC) of the bladder.

05 LaMB A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after first-line chemotherapy in patients with HER1 and/or HER2 overexpressing locally advanced or metastatic bladder cancer.

06 SELENIB Randomised controlled trial of selenium and vitamin E in the recurrence and progression of non muscle invasive bladder cancer (part of the Bladder Cancer Prognosis Programme). IRSTCN 13889738

07 SPARE SPARE – Randomised trial of Selective bladder Preservation Against Radical Excision (cystectomy) in muscle invasive T2/T3 transitional cell carcinoma of the bladder * feasibility study. IRSTCN 61126465

08 LEG 2004 06 (Wilms tumour survivors)

Study to investigate lung function following pulmonary radiotherapy in Wilms tumour survivors (LEG 2004 06).

09 WT 2001 02 (UKWR) Protocol for the treatment of relapsed and refractory Wilms tumour and Clear Cell Sarcoma of the kidney UKWR (WT 2001 02).

10 WT 2002 01 (SIOP Wilms)

SIOP Nephroblastoma Clinical Trial and Study (WT2002-01).

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GC 2005 04 (Germ Cell 3)

Protocol for the treatment of extracranial germ cell tumours in children & adolescents (GC-3).

12 ACTIVE SURVEILLANCE A study of active surveillance for early prostate cancer.

13 BiPAS The Birmingham Prostate Cancer Association Study – A genetic and environmental case control study on prostate cancer in Birmingham.

14 CHHIP Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer. IRSTCN 97182923

15 Coping with Cancer Socio-economic Status and Coping with Cancer. Examining the Experience of People Recently


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Diagnosed with Cancer. 16 Flomax Prophylactic Flomax in prostate cancer 17 FOCAL – HIFU An Evaluation of Focal Ablation Therapy using

High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate.

18 HEMI-HIFU An evaluation of hemi-ablation therapy using high-Intensity focused ultrasound in the treatment of localised adenocarcinoma of the prostate. IRSTCN 25145525

19 IMPACT Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted Screening in BRCA1/2 mutation carriers and controls – IMPACT.

20 MAPS Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): multicentre randomised controlled trial of pelvic floor muscle training, biofeedback and bladder training. IRSTCN 87696430

21 PATCH Prostate Adenocarcinoma: TransCutaneous Hormones. A randomised-controlled trial of transcutaneous oestrogen patches versus LHRH analogues in prostate cancer. IRSTCN 70406718

22 Pelvic IMRT for prostate cancer

A Phase 1 dose escalation study of the use of intensity modulated radiotherapy (IMRT) to treat the prostate and pelvic nodes in patients with prostate cancer.

23 PRECIOUS Improving the assessment and recording of cancer treatment effects.

24 ProSTART A phase III study of active surveillance therapy against radical treatment in patients diagnosed with favourable risk prostate cancer (start).

25 ProtecT The ProtecT Trial – Evaluating the effectiveness of treatment for clinically localised prostate cancer. IRSTCN 20141297

26 RADICALS (MRC PR10) Radiotherapy and Androgen Deprivation In Combination After Local Surgery. IRSTCN 40814031

27 RAPPER Radiogenomics: assessment of polymorphisms for predicting the effects of radiotherapy.

28 RIB A multicentre randomised trial of single dose Radiotherapy compared to Ibandronate for localised metastatic bone pain. IRSTCN 86185157

29 Stampede Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy. IRSTCN 78818544

30 TRAPEZE (PIII) A randomised phase II/III trial of docetaxel plus prednisolone vs. docetaxel plus prednisolone plus zoledronic acid vs. docetaxel plus prednisolone plus strontium-89 vs. docetaxel plus prednisolone plus zoledronic acid plus strontium-89 in hormone refract. IRSTCN 12808747

31 UK Genetic Prostate Cancer Study

UK Genetic Prostate Cancer Study.

32 SORCE A phase III Randomised Controlled Study Comparing Sorafenib With Placebo In Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse.

33 TRANSORCE (sub-study of SORCE)

A study to collect blood and tissue samples from consenting patients who have been diagnosed with


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renal cell cancer. 34 Accelerated BEP Accelerated BEP chemotherapy for intermediate

and high risk metastatic germ cell tumour. 35 BEP Continuous

Infusional Bleomycin – TE3

A randomised Phase III Toxicity Study of Day 2,8,15 Short (30 Minute) Versus Day 1,2,3 Long (72 Hours) Infusion Bleomycin for Patients with IGCCCG Good Prognosis Germ Cell Tumours.

36 Familial TGCT Identification and molecular analyses of families with susceptibility to Testicular Germ Cell Tumour Cancer.

37 Gem-TIP Phase I/II multicentre trial of salvage chemotherapy with Gem-TIP for relapsed germ cell cancer.

38 TE21/EORTC 30983 Randomised Phase II/III Study of Taxol-BEP versus BEP in patients with Intermediate Prognosis Germ Cell Cancer.

39 TE23 Randomised Phase II trial of intensive induction chemotherapy (CBOP/BEP) and standard BEP chemotherapy in poor prognosis male germ cell tumours. IRSTCN 53643604

40 The Late CT Study Assessment of the utility of CT follow up in the long term follow up of patients with metastatic non seminomatous germ cell tumour.

41 The UK Genetics of Testicular Cancer Study

Identification of testicular germ cell tumour susceptibility genes.

42 TRISST Trial of imaging and schedule in seminoma testis. IRSTCN 65987321

43 S-TRAC Sunitinib Treatment of Renal Adjuvant Cancer (s-trac): A randomised double-blind phase 3 study of adjuvant Sunitinib vs. placebo in subjects with high risk rcc.

44 BA11 Randomised phase III study comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in patients with metastatic or locally advanced urothelial cancer without prior systemic therapy [EORTC 30987].

45 BC2001 A randomised phase III study of radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer. IRSTCN 68324339

46 BCON A Multicentre Randomised Trial of Radical Radiotherapy with Carbogen in the Radical Radiotherapy of Locally Advanced Bladder Cancer IRSTCN 45938399

47 BS06 A Randomised Study of Radical Radiotherapy in the Management of pT1G3 NxM0 Transitional Cell Carcinoma of the Bladder. IRSTCN 65282717

48 EORTC 30986 Randomised phase II/III study assessing gemcitabine with carboplatin and methotrexate with carboplatin and vinblastine in previously untreated patients with urothelial cancer ineligible for cisplatin based chemotherapy.

49 Gem v Mv Randomised phase II study of Gemcitabine (Gem) or Methotrexate and Vinblastine (Mv) in advanced transitional cell carcinoma of the urothelium.

50 MCM5 Evaluation of urinary MCM5 as a diagnostic agent in genito-urinary malignancy.

51 ODMIT C A multicentre, prospective, randomised study to the value of a single dose of intravesical mitomycin in preventing the development of bladder tumours following nephroureterectomy for transitional cell


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carcinoma of the upper urinary tract. 52 Pittsburgh Study Investigation of suspected alterations in

cytochrome activity in patients with bladder cancer by validated drug-cocktail protocol.

53 RT with Weekly GEM Phase II study of radiotherapy with concurrent weekly gemcitabine in muscle-invasive bladder cancer. IRSTCN 13889738

54 GC 1989 01 Germ Cell Tumour Study II. 55 BUMPS Behavioural Urinary Management for Prostate

Symptoms: A phase II trial for testing feasibility of a self-management intervention for urinary problems following prostate radiotherapy.

56 Cardiovascular Prostate Study

An open study of cardiovascular and osteoporotic risk factors in patients undergoing androgen deprivation therapy for prostate cancer.

57 CV247 A randomised double-blind local phase III study of CV247 vs salicyclic acid in early prostate cancer.

58 DA v DAS in prostate cancer

A Randomised Phase III Trial of Dexamethasone and Aspirin (DA) Versus Dexamethasone, Diethylstilbestrol and Aspirin (DAS) in Locally Advanced or Metastatic Cancer of the Prostate. IRSTCN 13255144

59 EORTC 22991 Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy alone vs Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy plus adjuvant hormonal therapy in localised T1b-c, T2a, N0, M0 prostatic carcinoma.

60 EORTC 30985 Intermittent androgen deprivation in patients with stage D2 prostate cancer-Phase III.

61 High Dose Rhenium High Activity Rhenium-186 HEDP with peripheral blood stem cell support in patients with bony metastases in prostate cancer.

62 HIPRO Hypofractionated Dose Escalation utilising Intensity Modulated Radiotherapy (IMRT) in Carcinoma of the Prostate.

63 IHT in prostate cancer Intermittent androgen deprivation in patients with prostate cancer.

64 Intercontinental INTERmittent or CONTINuos ENdocrine Therapy After failure in Localised prostate cancer. IRSTCN 22761545

65 NCRN001 (Onyvax P) NCRN001 (Onyvax P). 66 PCSS The Prostate Cancer Symptoms Study. 67 PR07 A Randomised trial of Hormone Therapy plus

Radical radiotherapy versus Hormone Therapy alone in Non-Metastatic Prostate Cancer. IRSTCN 24991896

68 Process Prostate Cancer in Ethnic Subgroups: A comparative study of Incidence, Clinical Presentation and access to Health Care in the UK (Process).

69 Prostate & Cognition An exploratory pilot study to investigate whether hormonal therapy for prostate cancer has an adverse effect on cognition.

70 Prostate HDR brachytherapy boost trial

Randomised trial of interstitial brachytherapy as a component of radical radiotherapy for localised prostatic cancer.

71 RAACS Rural accessibility and cancer survival. 72 RT01 A Randomised Trial of High Dose Therapy in


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Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques. IRSTCN 47772397

73 SPIRIT A Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients with T1c or T2a N0 M0 Prostate Cancer.

74 TAPS Targeted PSA screening for familial prostate cancer.

75 HYDRA Adjuvant Interleukin-2, Interferon-Alpha and 5-Fluorouracil for Patients with high risk of relapse after surgical treatment for Renal Cell Carcinoma. IRSTCN 16387614

76 IL2 SRL +/- 172 A phase II randomised prospective study comparing Interleukin-2 versus Interleukin-2 with SRL 172 in patients with Advanced Renal Cell Carcinoma.

77 RE04 A randomised trial of interferon-alpha , interleukin-2 and 5-fluorouracil versus interferon-alpha alone in advanced renal cell cancer. IRSTCN 45618965

78 Annual Zoledronate Effect of an annual infusion of Zoledronate on bone mineral density in patients on long term follow up with cancer remission and anti neoplastic treatment induced bone loss study.

79 Long Term Effects of Chemo on Bone

An investigation of the long term effect of chemotherapy on bone, particularly focusing on the incidence of osteoporosis in such patients.

80 SIGNIFICANT A Randomised prospective double-blind, placebo controlled trial of prophylactic oral levofloxacin following chemotherapy for lymphoma and solid tumours. IRSTCN 49693355

81 TE08 A randomised Trial of Two CT Scans Versus Five CT Scans in the Surveillance of Patients with Stage I Teratoma of the Testis. IRSTCN 56475197

82 TE22 A study of 18-FDG PET in the prediction of relapse in patients with a �leomyci stage I non-seminomatous germ cell tumour.

83 TER2 Risk of testis cancer in the families of patients with bilateral testicular germ cell malignancy.

84 TIP A phase II study of paclitaxel, cisplatin and Ifosfamide as induction therapy in the treatment of patients relapsing after BEP (bleomycin, etoposide, cisplatin) chemotherapy for patients with metastatic germ cell tumours.

85 CPT11 and Cisplatin for penile carcinoma

International multicentre trial of Irinotecan (CPT11) and Cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC 30992).

86 ABR-217620 A trial looking at ABR-217620 in combination with interferon for advanced renal cell cancer.

87 SUCCINT Sunitinib in advanced Urothelial CanCer IN Combination with standard cisplatin/gemcitabine chemotherapy Treatment

88 TOTEM Trial of Temsirolus for Advanced Urothelial Cancer 89 AXIS 96 Not Applicable Patient not entered into any clinical trials. 98 Other (specify) 99 Not known

Attributes:


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Status Open

Closed Related data items: Participant in Clinical Trial Clinical Trial Formal Entry Date Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.6 Clinical Features

Definition: The clinical features reported by the patient or identified clinically. Format: Characters Field length: 3 Codes and values: Code Value Sub-

codeSub-value Explanatory Notes

01 Swelling(s) Abnormal prominence or protuberance.

02 Lump(s) Mass of body structure. A Visible haematuria

03 Bleeding

B Invisible haematuria Includes dipstick and microscopic.

04 Weight Loss (Significant)

Significant weight loss is usually >10% loss of weight in the past six months which is not attributable to lifestyle changes (e.g. dieting) or other medical conditions.

05 Fatigue A Phimosis. B Paraphimosis C Curvature D Hypospadias E Abnormal Size E.g swelling or shrinkage. F Maldescended testes

06 Anatomical structural problem

Z Other (specify) 07 Discharge

A Body part

discolouration

B Discoloured discharge

C Discoloured urine Not including haematuria.

08 Discolouration

Z Other (specify) 09 Dyspnoea 10 Nausea 11 Vomiting 12 Headache 13 Dizziness 14 Visual disturbances 15 Perspiration 16 Urinary retention 17 Dysuria

A Urgency of

micturition

18 Urinary bladder voiding

B Frequency of micturition


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C Hesitancy of micturition

D Dribbling of urine E Incontinence F Straining to void G Sensation of

incomplete emptying

H Slow urine stream J Nocturnal enuresis K Nocturia Z Other (specify)

19 Pyrexia 20 Anxiety 21 Persistent cough 22 Ulcer 23 Warts 24 Abscess 25 Fistulae 26 Lesion 27 Plaques 28 Rash 29 Spot 30 Pain

A Increased sensation B Reduced sensation C Absence of

sensation

D Sensation of heaviness

E Tenderness

31 Abnormal sensation

Z Other (specify) A Deep vein

thrombosis

B Superficial thrombosis

C Venous thromboembolism

D Pulmonary thrombolembolism

32 Thromboembolism

Z Other (specify) 33 Anorexia 34 Abnormal serum marker 35 Abnormal Cell detection 36 Priapism 37 Paraneoplastic

phenomena

96 Not applicable 98 Other (specify) 99 Not known

Attributes: Timing of presentation

Anticedent At presentation At diagnosis


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Post treatment With disease progression

Anatomical Site Laterality Feature type Sign

Symptom Status New

Resolved Static/ No change Continuance

Transitory (Symptom completely resolved between onset and assessment) Recurrent (Symptom has completely resolved then re-occurred at least once between onset and assessment)

Persistent (Symptom not fully resolved at the time of assessment) Severity Mild Moderate Severe Frequency

All of the time Most of the time Several times a day Once a day Several times a week Once a week Less than once a week

Episodicity Continuous Intermittent

Chronicity Acute

Chronic Related data items: Duration (Symptom) Most Valid Basis of Diagnosis {Cancer} Metastatic Status {Cancer} Metastases Site(s) Serum Marker Fistula Sites Recording guidance: IT systems should allow for the recording of multiple values for this item.


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Users may wish to augment code ’98 – Other (specify)’ and sub-codes ‘Z - Other (specify)’ with a free text field for recording other values of this item. This item may occur more than once throughout a patient’s record.

2.7 Bisphosphonate Agent

Definition: The type of bisphosphonate agent administered. Format: Characters Field length: 2 Codes and values: Code Value 01 Zoledronic acid 02 Sodium clodronate 03 Disodium pamidronate 04 Ibandronic acid 05 Alendronic acid 96 Not applicable 98 Other (specify) 99 Not known

Related data items: Treatment Modalities {Cancer} Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.8 Radionuclide

Definition: The type of Radionuclide administered. Format: Characters Field length: 2 Codes and values: Code Value 01 89Strontium 02 186Rhenium 03 153Samarium 04 226Radium 05 125Iodine 06 192Iradium

07 103Palladium


Related data items: Treatment Modalities {Cancer} Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.9 Adverse Outcomes

Definition: Any adverse outcome to the patient occurring following an intervention. Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value

A Anastamotic stricture B Urethral stricture C Ureteric stricture

01 Stricture

Z Other (specify) 02 Deep venous thrombosis (DVT) 03 Pain

A Wound hernia

04 Hernia

Z Other (specify) A Wound infection B Device infection C Recurrent urinary tract infection D Systemic infection E Neutropenic sepsis

05 Infection

Z Other (specify) 06 Renal impairment 07 Lymphocoeles 08 Lymphoedema 09 Pulmonary embolism

A Major Bleeding requiring

transfusion

10 Bleeding

B Minor Bleeding 11 Rectal injury 12 Fistula

A Faecal continence issues

13 Continence issues

B Urinary continence issues A Infertility B Anejaculation C Erectile dysfunction

14 Sexual dysfunction

Z Other (specify) 15 Bladder neck obstruction 16 Utereric obstruction 17 Urinary retention 18 Subvesical obstruction 19 Loss of libido 20 Proctitis 21 Further tumour invasion (outside

organ)

22 Constipation 23 Device failure


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24 Device displacement 25 Myocardial infarction (M I) 26 Fatigue 27 Stroke 28 Weight loss 29 Malignancy

30 Recurrence A Local/ Regional recurrence A Local/ Regional progression

31 Progression

B Distant progression 32 Death 33 Thrombosis 34 Stoma problems 35 Cystitis 36 Haematuria 37 Diarrhoea 38 Small bowel obstruction 39 Overall gastrointestinal toxicity 40 Leg Oedema 41 Skin toxicity 42 Tenesmus 43 Ulceration 44 Dysuria 45 Telangiectasia 46 Insomnia 47 Hot flushes 48 Gynaecomastia 49 Change in body fat 50 Muscle wasting 51 Anaemia 52 Neutropenia 53 Thrombocytopenia 54 Liver dysfunction 55 Cognitive decline 56 Cardiovascular toxicity 57 Osteoporosis 96 Not applicable 98 Other (specify) 99 Not known Attributes: Timing

Acute – Please see further information for guidance. Late - Please see further information for guidance.

Event type

Potential event Actual event

Anatomical site Severity Mild Moderate


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Severe Related data items: Complications Timing Treatment Modalities {Cancer} Surgical Procedure (Urological Cancer) Medication or Device Name Risk Status Level Date of diagnosis {Cancer} Treatment Related Morbidity Type(s) of Continence Problem Identified (Bladder Continence) Fistula Sites Pre-Void Urine Volume Post-Void Residual Urine Volume Episodes of Bowel Incontinence Further information: The definitions for the Timing attributes are: Acute - Occurring within three months of completion of treatment. Late - Occurring three months or more after completion of treatment. Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ and sub-codes ‘Z – Other (specify) with a free text field for recording other values of this item.

2.10 Complications Timing

Definition: The timing of complication(s). Format: Characters Field length: 2 Codes and values: Code Value Sub-code Sub-value 01 Intraoperative

A 1 day post-operatively B 2 -7 days post-operatively C 8 -30 days post-operatively

02 Post-Operative

D >30 days post-operatively 96 Not applicable 98 Other (specify) 99 Not known

Related data items: Adverse Outcomes Recording guidance: IT systems should allow for the recording of multiple values for this item.


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Users may wish to augment code ‘98 – Other (specify)’ with a free text field for recording other values of this item.

2.11 Surgical Procedure (Urological Cancer)

Definition: The surgical procedure(s) performed for investigation and treatment of cancer. This also includes nodal and reconstructive surgery performed on the patient for treatment of cancer. Format: Characters Field length: 3 Codes and values: Code Value Sub-code Sub-value Explanatory Notes

01 Excision lesion A Mohs surgery A Diversion B Ureteric re-implantation C Boari flap creation D Transuretero-ureterostomy

02 Reconstructive surgery

Z Other (specify) 03 Glansectomy 04 Penectomy 05 Lymphadenectomy

A Partial cystectomy B Sub-total cystectomy

06 Cystectomy

C Cystoprostatectomy 07 Urethrectomy 08 Nephroureterectomy

A Finger guided biopsy B US guided biopsy C CT guided biopsy

09 Biopsy

Z Other (specify) 10 Trans urethral

resection of the prostate (TURP)

A Open enucleation

prostatectomy

11 Prostatectomy

B Radical/total excision prostatectomy

12 Dissection A Subcapsular orchidectomy

B Scrotal orchidectomy

13 Orchidectomy

C Inguinal orchidectomy


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14 Nephrectomy 15 Ureterectomy 16 Trans urethral

resection bladder tumour(TURBT)

17 Adrenalectomy

18 Endoscopic ablation of the prostate

19 Ureterostomy

20 Prosthesis procedure

21 Circumcision

22 Insertion of abdominal drain

23 Nephrostomy

A Retrograde ureteric stent

insertion

24 Ureteric stent insertion

B Antegrade Ureteric stent insertion

25 Orthotopic reconstruction

A Wallace I Wallace 66

B Wallace II Wallace 69

26 Ileal conduit

C Bricker

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Continent cutaneous diversion

28 Rectal diversion

29 Vesiculectomy


Sub-data items: Surgical Considerations Code Value Explanatory Notes 01 Conservative Surgery E.g. nephron/nerve sparing. 02 Salvage therapy Attributes: Anatomical site Laterality


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Extent Partial Total Simple Radical

Lymphadenectomy node type

Sentinel Regional

Nephroureterectomy type

With bladder cuff Without bladder cuff

Related data items: Surgical Procedure Intent Surgical Procedure Type (Colorectal Cancer) Vena Cava Exploration Type Prosthesis status Urinary Catheterisation Reason Sentinel Node Biopsy Ablation Energy Source Bladder Reconstruction Type Replacement Tissue Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ and sub-codes ‘Z – Other (specify)’ with a free text field for recording other values of this item.

2.12 Laparoscopic Procedure Type

Definition: The type of laparoscopic procedure. Format: Characters Field length: 2 Codes and values: Code Value 01 Straight approach 02 Hand assisted 03 Robotic 98 Other (specify) Related data items: Surgical Procedure (Urological Cancer) Surgical Procedure Access Surgical Procedure Type (Colorectal Cancer) Recording guidance:


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IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.13 Surgical Procedure Access

Definition: The route of access used in a surgical procedure. Format: Characters Field length: 3 Codes and values: Code Value Sub-code Sub-value 01 Retropubic 02 Perineal

A Extraperitoneal

03 Peritoneal

B Transperitoneal 04 Loin 05 Thoraco-abdominal 06 Retroperitoneal 07 Transinguinal 08 Transcrotal 09 Transvesical 10 Penile 11 Transrectal 12 Transurethral 96 Not applicable 98 Other (specify) 99 Not known

Related data items: Surgical Procedure (Urological Cancer) Surgical Procedure Type (Colorectal Cancer) Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.14 Laser Type

Definition: The type of laser. Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 01 Carbon Dioxide CO2 02 Argon Ar 03 Neodymium: Yttrium-

Aluminium-Garnet Nd:YAG

04 Holmium: Yttrium-Aluminium-Garnet

Ho: YAG


Attributes: Laser procedure

Incision Coagulation Ablation Enucleation

Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.15 Vena Cava Exploration Type

Definition: The type of vena cava exploration. Format: Characters Field length: 3 Codes and values: Code Value Sub-code Sub-value

A Subhepatic

01 Infradiaphragmatic

B Hepatic 02 Supradiaphragmatic 96 Not applicable 98 Other (specify) 99 Not known

Related data items:


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Surgical Procedure (Urological Cancer) Recording guidance: IT systems should allow for the recording of multiple values for this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.16 Prosthesis Status

Definition: The status of patient prosthesis. Format: Characters Field length: 2 Codes and values: Code Value 01 Prosthesis inserted. 02 Prosthesis removed. 03 Prosthesis declined 96 Not applicable 98 Other (specify) 99 Not known

Attributes: Anatomical site Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.17 Prosthesis Offered

Definition: An indication of whether or not the patient was offered a prosthesis. Format: Characters Field length: 2 Codes and values: Code Value 00 No 01 Yes 99 Not known

Related data items: Prosthesis Status


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2.18 Reason for Scrotal Approach

Definition: The reason for a scrotal surgical approach. Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 01 Intentional E.g. technical reasons; Alternative not feasable;

Optimal approach. 02 Undiagnosed tumour 96 Not applicable 98 Other (specify) 99 Not known

Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.19 Type of Specimen (Urological Cancer)

Main source of standard: The Royal College of Pathologists, Dataset Adult Renal Parenchymal Cancer Histopathology Reports, November 2006. Definition: The type of specimen submitted. Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value Explanatory

Notes 01 Cytology specimen

A Punch B Incisional C Excisional D Single needle E Cold cup F Resectional G Multiple needle

02 Biopsy specimen

Z Other (specify) 03 Partial nephrectomy specimen 04 Total nephrectomy specimen 05 Radical nephrectomy specimen

A With bladder cuff

06 Radical Nephro-ureterectomy specimen

B Without bladder cuff 07 Total Nephro-ureterectomy Specimen


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A With bladder cuff B Without bladder cuff

08 Ureterectomy specimen A Exophytic Tumour B Deep muscle

09 Transurethral resection of bladder tumour specimen (TURBT)

C Random biopsy 10 Diverticulectomy specimen

A Partial B Radical C Cystoprostatectomy

specimen

11 Cystectomy specimen

D Urethrectomy specimen

12 Transurethral Resection of Prostate Specimen

(TURP)

13 Open Enucleation of Prostate 14 Radical Prostatectomy Specimen 15 Seminal Vesicle Specimen

A Simple Subcapsular

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Orchidectomy Specimen

B Radical 17 Lymph node specimen 18 Circumcision specimen 19 Glansectomy specimen 20 Partial penectomy specimen 21 Total penectomy specimen 96 Not applicable 98 Other (specify) 99 Not known Attributes: Laterality Anatomical site Bladder SubSite

Neck Trigone Ureteric orifice Lateral wall Anterior wall Posterior wall

Related data items: Surgical Procedure Type (Colorectal Cancer) Date Histo/Cytopathological Specimen Taken Number of Needle Cores Surgical Procedure (Urological Cancer) Recording guidance: IT systems should allow for multiple recording of this item.


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Users may wish to augment code ‘98 – Other (specify)’ and sub-code ‘Z – Other (specify)’ with a free text field for recording other values of this item. This item may occur more than once throughout a patient’s record.

2.20 Fistula Sites

Definition: The anatomical structures connected by a fistula according to the Systematized Nomenclature of Medicine (SNOMED-CT) Topography. Format: Characters Field length: Minimum 18 Codes and Values: Code Value SCT specific code(s) SCT specific term(s) for specific Anatomical Site 96 Not applicable 98 Other (specify) 99 Not known

Attributes: Laterality Related data items: Side Effects of External Beam Radiotherapy {Cancer} Recording guidance: IT systems should allow for multiple recording of this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.21 Serum Marker Definition: The serum marker used. Format: Characters Field length: 2 Codes and values: Code Value 01 Prostate specific antigen (PSA) 02 Alpha-fetoprotein (AFP) 03 Human chorionic gonadotrophin (HCG) 04 Lactate dehydrogenase (LDH) 96 Not applicable 98 Other (specify)

Related data items:


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Clinical Features Prostate Specific Antigen (PSA) Assay Recording guidance: IT systems should allow for multiple recording of this item. Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.22 Needle Core Site

Main source of standard: The Royal College of Pathologists, Minimum Dataset for Prostate Cancer Histopathology Reports, April 2000. Definition: A record of the site where the needle cores were obtained. Format: Characters Field length: 2 Codes and values: Code Value 01 Lateral/Peripheral prostate 02 Apex of the prostate 03 Base of the prostate 04 Transitional prostate zone 05 Mid prostate zone 06 Seminal Vesicle 96 Not applicable 99 Not known

Attributes: Laterality

Anatomical Site

Related data items: Number of Needle Cores Length of Needle Cores Recording guidance: IT systems should allow for multiple recording of this item.


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2.23 Number of Needle Cores

Main source of standard: The Royal College of Pathologists, Minimum Dataset for Prostate Cancer Histopathology Reports, 2009. Definition: The number of needle cores. Format: Numeric (nn) Field length: 2 Codes and values: N/A Attributes: Related Activity

Taken Submitted Received Involved Not assessable

Related data items: Needle Core Site Length of Needle Cores

2.24 Sentinel Lymph-node Dye Type Definition: The type of dye used with sentinel lymph-node imaging procedures. Format: Characters Field length: 2 Codes and values: Code Value 01 Isosulphan blue 02 Technetium-99m sulphur colloid96 Not applicable 98 Other (specify)

Related data items: Sentinel Node Biopsy Sentinel Lymph-node Dye Identified Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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2.25 Sentinel Lymph-node Dye Identified

Definition: An indication of whether or not the sentinel lymph-node has been identified by dying. Format: Characters Field length: 2 Codes and values: Code Value 00 No 01 Yes 99 Not known

Related data items: Sentinel Lymph-node Dye Type

2.26 Saphenous Vein Preserved

Definition: An indication of whether the saphenous vein was preserved during surgery. Format: Characters Field length: 2 Codes and values: Code Value 00 Not preserved 01 Preserved 96 Not applicable

Related data items: Surgical Procedure (Urological Cancer)

2.27 Number of Freeze Thaw Cycles Definition: The number of freeze-thaw cycles used in cryosurgery. Format: Numeric (nn) Field length: 2 Codes and Values: N/A Related data items: Ablation Energy Source Number of Cryo Needles


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2.28 Number of Cryo Needles Definition: The number of cryo needles used in cryosurgery. Format: Numeric (nn) Field length: 2 Codes and Values: N/A Related data items: Ablation Energy Source Number of Freeze Thaw Cycles

2.29 Predisposing Factor(s) of Urological Cancer Common name: Aetiology of Urological Cancer Definition: The cause or predisposing factor(s) of urological cancer. Format: Characters Field length: 3 Codes and Values: Code Value Sub-code Sub-value 01 Family history 02 Smoking 03 Previous radiotherapy 04 Genetic predisposition 05 Obesity 06 Human papilloma virus 07 Maldescended testis 08 Occupational exposure

A Asbestos exposure B Lead exposure C Cadmium exposure

09 Chemical exposure

Z Other (specify) A Chrysodine exposure B Aniline exposure C Benzidine exposure

10 Dye exposure

Z Other (specify) 11 Mumps orchitis 12 Low sperm count 13 Previous cancer 14 Repeated bladder infections 15 Bladder stones 16 Diet 17 High blood pressure 18 Kidney disease


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19 Use of kidney dialysis 20 Anti-inflammatory drugs 21 Painkillers 22 Previous chemotherapy 23 Previous surgery 96 Not applicable 98 Other (specify) 99 Not known

Related data items: Genetic (blood) Relationship/ Degree of Relative Occupation Duration Duration (Descriptive) Recording guidance: IT systems should allow for multiple recording of this item. Users may wish to augment code ’98 – Other (specify)’ and sub-codes ‘Z – Other (specify)’ with a free text field for recording other values of this item.

2.30 Tumour Appearance Definition: The clinical appearance of the tumour. Format: Characters Field length: 2 Codes and values: Code Value 01 Sessile 02 Papillary 03 Red patch 04 Pedunculated 05 Solid 06 Necrotic 07 Ulcerated 08 Not identified 96 Not applicable 98 Other (specify) 99 Not known

Recording guidance: IT systems should allow for multiple recording of this item. Users may wish to augment code ‘98 – Other (specify)’ with a free text field for recording other values of this item.


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2.31 Bladder Reconstruction Type

Definition: The type of bladder reconstruction used. Format: Characters Field length: 2 Codes and values: Code Value 01 Structure 02 Drainage 96 Not applicable 98 Other (specify)

Related data items: Surgical Procedure (Urological Cancer) Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

2.32 Replacement Tissue

Definition: The tissue used as a replacement. Format: Characters Field length: 2 Codes and values: Code Value 01 Small bowel 02 Large bowel 03 Appendix 04 Small bowel spout 05 Skin 96 Not applicable 98 Other (specify)

Attributes: Anatomical site Laterality Related data items: Surgical Procedure (Urological Cancer) Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


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Section 3. Cancer of the Penis

3.1 TNM Tumour Classification (Clinical) (Cancer of the Penis)

Common name: Clinical TNM Tumour Classification (Cancer of the Penis). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the size and extent of the tumour of the penis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification T0 No evidence of primary tumour. 01 TNM Classification Ta Non-invasive verrucous carcinoma. 02 TNM Classification Tis Carcinoma in situ (CIS). 03 TNM Classification T1 Tumour invades subepithelial connective tissue. 04 TNM Classification T2 Tumour invades corpus spongiosum or cavernosum. 05 TNM Classification T3 Tumour invades urethra or prostate. 06 TNM Classification T4 Tumour invades other adjacent structures. 07 TNM Classification TX Primary tumour cannot be assessed. 99 Not known .

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Penis) TNM Metastases Classification (Clinical) (Cancer of the Penis)

3.2 TNM Nodal Classification (Clinical) (Cancer of the Penis)

Common name: Clinical TNM Nodal Classification (Cancer of the Penis). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the penis metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2


44

Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Metastasis in a single superficial inguinal lymph node. 02 TNM Classification N2 Metastasis in multiple or bilateral superficial inguinal

lymph nodes. 02 TNM Classification N3 Metastasis in deep inguinal or pelvic lymph node(s),

unilateral or bilateral. 04 TNM Classification NX Regional lymph nodes cannot be assessed (e.g.

previously removed). 99 Not known

Related Data items: TNM Tumour Classification (Clinical) (Cancer of the Penis) TNM Metastases Classification (Clinical) (Cancer of the Penis)

3.3 TNM Metastases Classification (Clinical) (Cancer of the Penis)

Common name: Clinical TNM Metastases Classification (Cancer of the Penis). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the penis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification M0 No distant metastasis. 01 TNM Classification M1 Distant metastasis. 02 TNM Classification MX Distant metastasis cannot be assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Penis) TNM Tumour Classification (Clinical) (Cancer of the Penis)


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Section 4. Cancer of the Prostate

4.1 TNM Tumour Classification (Clinical) (Cancer of the Prostate)

Common name: Clinical TNM Tumour Classification (Cancer of the Prostate). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the size and extent of the tumour of the prostate as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value

Explanatory Notes

00 TNM Classification T0

No evidence of primary tumour.

Clinically inapparent tumour not palpable or visible by imaging.

A T1a Tumour incidental histological finding in 5% or less of tissue resected.

B T1b Tumour incidental histological finding in more than 5% of tissue resected.


C T1c Tumour identified by needle biopsy (e.g., because of elevated PSA).

Tumour confined within prostate. A T2a Tumour involves one half of one lobe or less. B T2b Tumour involves more than half of one lobe,

but not both lobes.


C T2c Tumour involves both lobes. Tumour extends through the prostatic capsule. A T3a Extra capsular extension (unilateral or

bilateral).


B T3b Tumour invades seminal vesicle(s). 04 TNM

Classification T4 Tumour is fixed or invades adjacent structures

other than seminal vesicles: bladder neck, external sphincter, rectum, levator muscles, or pelvic wall.

05 TNM Classification TX

Primary tumour cannot be assessed.

99 Not known Related data items: TNM Nodal Classification (Clinical) (Cancer of the Prostate) TNM Metastases Classification (Clinical) (Cancer of the Prostate)


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4.2 TNM Nodal Classification (Clinical) (Cancer of the Prostate)

Common name: Clinical TNM Nodal Classification (Cancer of the Prostate). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the prostate metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Regional lymph node metastasis. 02 TNM Classification NX Regional lymph nodes cannot be assessed (e.g.


Related Data items: TNM Tumour Classification (Clinical) (Cancer of the Prostate) TNM Metastases Classification (Clinical) (Cancer of the Prostate)

4.3 TNM Metastases Classification (Clinical) (Cancer of the Prostate)

Common name: Clinical TNM Metastases Classification (Cancer of the Prostate). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the prostate as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 3


47

Codes and values: Code Value Sub-code Sub-value Explanatory Notes 00 TNM

Classification M0 No distant metastasis.

Distant metastasis. A M1a Non-regional lymph node(s). B M1b Bone(s).

01 TNM Classification M1

C M1c Other site(s). 02 TNM

Classification MX Distant metastasis cannot be

assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Prostate) TNM Tumour Classification (Clinical) (Cancer of the Prostate)

4.4 Prostate Volume

Definition: The prostate volume measured in cubic centimetres. Format: Numeric (nnnn) Field length: 4 Codes and Values: N/A

4.5 Prostate Specific Antigen (PSA) Assay Definition: The type of prostate specific antigen assay used. Format: Characters Field length: 2 Codes and Values: Code Value 01 Beckman Access-Hybritech standard 02 Beckman Access-WHO standard 03 SMS Diagnostics-ADVIA Centaur 04 SMS Diagnostics- Immulite 2000 05 SMS Diag. -Immulite 2000 3rd Generation 06 SMS Diag. -Immulite 3rd Generation 07 Abbott AxSYM 08 Abbott Architect 09 Olympus 10 Roche E-170 11 Roche ELECSYS 12 Tosoh Eurogenetics 96 Not applicable 98 Other (specify)

Related data items:


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Serum Marker Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.

4.6 International Prostate Symptom Score (IPSS) Definition: The International Prostate Symptom Score. Format: Numeric (nn) Field length: 2 Codes and Values: N/A Related data items: International Prostate Symptom Score Bladder Emptying Sensation International Prostate Symptom Score Re-Urination Within Two Hours International Prostate Symptom Score Urination Hesitancy International Prostate Symptom Score Urination Postponing Difficulty International Prostate Symptom Score Urinary Stream Strength International Prostate Symptom Score Forced Urination International Prostate Symptom Score Number of Nocturia Episodes Further information: The International Prostate Symptom Score (IPSS) is calculated from the sum of the results of the following seven data standards.

International Prostate Symptom Score Bladder Emptying Sensation International Prostate Symptom Score Re-Urination Within Two Hours International Prostate Symptom Score Urination Hesitancy International Prostate Symptom Score Urination Postponing Difficulty International Prostate Symptom Score Urinary Stream Strength International Prostate Symptom Score Forced Urination International Prostate Symptom Score Number of Nocturia Episodes

Recording guidance: The international prostate symptom score values ranges from 0 (zero) to 35.


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4.7 International Prostate Symptom Score Bladder Emptying Sensation

Main Source of Standard: The American Urological Association. Definition: The patient’s description (based on the International Prostate Symptom Score) of how often they have had a sensation of not emptying their bladder completely after urinating, over the past month or so. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value 00 Not at all 01 Less than one time in five 02 Less than half the time 03 About half the time 04 More than half the time 05 Almost always

Related Data Items: International Prostate Symptom Score (IPSS)

4.8 International Prostate Symptom Score Re-Urination Within Two Hours

Main Source of Standard: The American Urological Association. Definition: The patient’s description (based on the International Prostate Symptom Score) of how often they have had to urinate again less than two hours after they have urinated, over the past month or so. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value 00 Not at all 01 Less than one time in five 02 Less than half the time 03 About half the time 04 More than half the time 05 Almost always



50

4.9 International Prostate Symptom Score Urination Hesitancy

Main Source of Standard: The American Urological Association. Definition: The patient’s description (based on the International Prostate Symptom Score) of how often they have stopped and started when they have urinated, over the past month or so. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value 00 Not at all 01 Less than one time in five 02 Less than half the time 03 About half the time 04 More than half the time 05 Almost always


4.10 International Prostate Symptom Score Urination Postponing Difficulty

Main Source of Standard: The American Urological Association. Definition: The patient’s description (based on the International Prostate Symptom Score) of how often they have found it difficult to postpone urination, over the past month or so. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value 00 Not at all 01 Less than one time in five 02 Less than half the time 03 About half the time 04 More than half the time 05 Almost always



51

4.11 International Prostate Symptom Score Urinary Stream Strength

Main Source of Standard: The American Urological Association. Definition: The patient’s description (based on the International Prostate Symptom Score) of how often they have had a weak urinary stream, over the past month or so. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value 00 Not at all 01 Less than one time in five 02 Less than half the time 03 About half the time 04 More than half the time 05 Almost always


4.12 International Prostate Symptom Score Forced Urination

Main Source of Standard: The American Urological Association. Definition: The patient’s description (based on the International Prostate Symptom Score) of how often they have had to push or strain to urinate, over the past month or so. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value 00 Not at all 01 Less than one time in five 02 Less than half the time 03 About half the time 04 More than half the time 05 Almost always



52

4.13 International Prostate Symptom Score Number of Nocturia Episodes

Main Source of Standard: The American Urological Association. Definition: The patient’s description (based on the International Prostate Symptom Score) of how many times they, most typically, got up to urinate from the time they went to bed at night until the time they got up in the morning, over the past month or so. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value 00 Never 01 One time 02 Two times 03 Three times 04 Four times 05 Five times or more


4.14 Quality of Life Due to Urinary Symptoms

Main Source of Standard: The American Urological Association. Definition: The patient’s description of how they would feel if they were to spend the rest of their life with their urinary condition the way it is now. Format: Numeric (nn) Field length: 2 Codes and Values: Code Value Explanatory Notes 00 Delighted 01 Pleased 02 Mostly satisfied 03 Mixed About equally satisfied and dissatisfied. 04 Mostly dissatisfied 05 Unhappy 06 Terrible


53

Section 5. Cancer of the Testis

5.1 TNM Nodal Classification (Clinical) (Cancer of the Testis)

Common name: Clinical TNM Nodal Classification (Cancer of the Testis). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the testis metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Metastasis with a lymph node mass 2 cm or less in

greatest dimension or multiple lymph nodes, none more than 2 cm in greatest dimension.

02 TNM Classification N2 Metastasis with a lymph node mass more than 2 cm but not more than 5 cm in greatest dimension, or multiple lymph nodes, any one mass more than 2 cm but not more than 5 cm in greatest dimension.

02 TNM Classification N3 Metastasis with a lymph node mass more than 5 cm in greatest dimension.

04 TNM Classification NX Regional lymph nodes cannot be assessed (e.g. previously removed).

99 Not known Related Data items: TNM Metastases Classification (Clinical) (Cancer of the Testis)

5.2 TNM Metastases Classification (Clinical) (Cancer of the Testis)

Common name: Clinical TNM Metastases Classification (Cancer of the Testis). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the testis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 3


54

Codes and values: Code Value Sub-code Sub-value Explanatory Notes 00 TNM

Classification M0 No distant metastasis.

Distant metastasis. A M1a Non-regional lymph node(s) or

lung.

01 TNM Classification M1

B M1b Other sites.

02 TNM Classification MX

Distant metastasis cannot be assessed.

99 Not known

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Testis)

5.3 Royal Marsden Hospital (RMH) Staging

Main source of standard: SIGN Guideline 28: Management of Adult Testicular Germ Cell Tumours. Definition: The patient’s Royal Marsden Hospital (RMH) staging. Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value

Explanatory Notes

No evidence of disease outside the testis. 01 RMH stage I A I M As above but with persistently raised tumour

markers. Infradiaphragmatic nodal involvement. A II A Maximum diameter < 2cm. B II B Maximum diameter 2 – 5cm. C II C Maximum diameter >5 – 10cm.

02 RMH stage II

D II D Maximum diameter > 10cm. 03 RMH stage III Supra and Infradiaphragmatic node

involvement. Abdominal nodes A, B, C as above Mediastinal nodes M+ Neck nodes N+

04 RMH stage IV Extralymphatic metastases. Abdominal nodes A, B, C as above Mediastinal or neck nodes as for stage 3 Lungs: L1 < 3 metastases L2 Multiple metastases 2cm maximum diameter L3 Multiple metastases > 2cm in diameter Liver involvement H+ Other sites specified

99 Not known


55

5.4 International Germ Cell Consensus Classification (IGCCC) Prognostic Grouping

Main source of standard: Journal of Clinical Oncology 1996 Definition: The patient’s prognostic group based on the International Germ Cell Concensus Classification (IGCCC) prognostic grouping. Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 01 Good Teratoma (NSGCT) with all of:

Testis/retroperitoneal primary No non-pulmonary visceral metastases AFP < 1,000 ng/ml HCG < 5000 iu/l LDH < 1.5 upper limit of normal (56% of teratomas) (5-year survival 92%)

Seminoma with all of: Any primary site No non-pulmonary visceral metastases Normal AFP Any HCG Any LDH (90% of seminomas) (5-year survival 86%)

02 Intermediate Teratoma (NSGCT) with all of: Testis/retroperitoneal primary No non-pulmonary visceral metastases AFP 1,000 and 10,000ng/ml or HCG 5,000 and 50,000 iu/l or LDH 1.5 normal 10 normal (28% of teratomas) (5-year survival 80%)

Seminoma with all of: Any primary site Non-pulmonary visceral metastases Normal AFP Any HCG Any LDH (10% of seminomas) (5-year survival 73%)

03 Poor Teratoma (NSGCT) with any of: Mediastinal primary or non-pulmonary visceral metastases AFP > 10,000 ng/ml or HCG > 50,000 iu/l or LDH > 10 normal (16% of teratomas) (5-year survival 48%)

Seminoma with any of: No patients classified as poor prognosis

99 Not known


56

5.5 S Category

Common name: Serum Tumour Marker Level Category (Testicular Cancer). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the serum tumour marker levels obtained immediately after orchidectomy, coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 01 S0 Serum marker study levels within normal limits. 02 S1 LDH <1.5 * N and hCG <5,000(mIU/ml) and AFP < 1000 (ng/ml). 03 S2 LDH 1.5-10* N or hCG 5,000 – 50,000 (mIU/ml) or AFP 1,000 -10,000

(ng/ml). 04 S3 LDH >10 * N or hCG >50,000(mIU/ml) or AFP >10,000 (ng/ml). 05 Sx Serum markers not available or not performed. 99 Not

known

Further information: N indicates the upper limit of normal for the LDH assay.


57

Section 6. Cancer of the Kidney

6.1 TNM Tumour Classification (Clinical) (Cancer of the Kidney)

Common name: Clinical TNM Tumour Classification (Cancer of the Kidney). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the size and extent of the tumour of the kidney as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value

Explanatory Notes



Tumour 7 cm or less in greatest dimension, limited to the kidney.

A T1a Tumour 4 cm or less.


B T1b Tumour more than 4 cm but not more than 7 cm.


Tumour more than 7 cm in greatest dimension, limited to the kidney.

Tumour extends into major veins or directly invades adrenal gland or perinephric tissues but not beyond Gerota fascia.

A T3a Tumour directly invades adrenal gland or perinephric tissues but not beyond Gerota fascia. Includes renal sinus (peripelvic) fat.

B T3b Tumour grossly extends into renal vein(s) or vena cava or its wall below diaphragm. Includes segmental (muscle-containing) branches.


C T3c Tumour grossly extends into vena cava or its wall above diaphragm.


Tumour directly invades beyond Gerota fascia.



99 Not known Related data items: TNM Nodal Classification (Clinical) (Cancer of the Kidney) TNM Metastases Classification (Clinical) (Cancer of the Kidney)


58

6.2 TNM Nodal Classification (Clinical) (Cancer of the Kidney)

Common name: Clinical TNM Nodal Classification (Cancer of the Kidney). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the kidney metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Metastasis in a single regional lymph node. 02 TNM Classification N2 Metastasis in more than one regional lymph node. 03 TNM Classification NX Regional lymph nodes cannot be assessed (e.g.


Related Data items: TNM Tumour Classification (Clinical) (Cancer of the Kidney) TNM Metastases Classification (Clinical) (Cancer of the Kidney)

6.3 TNM Metastases Classification (Clinical) (Cancer of the Kidney)

Common name: Clinical TNM Metastases Classification (Cancer of the Kidney). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the kidney as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification M0 No distant metastasis. 01 TNM Classification M1 Distant metastasis. 02 TNM Classification MX Distant metastasis cannot be assessed. 99 Not known


59

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Kidney) TNM Tumour Classification (Clinical) (Cancer of the Kidney)

6.4 Leibovich Risk Category

Definition: The risk category of disease progression after radical nephrectomy for patients with clear cell renal cell carcinoma. Format: Characters Field length: 2 Codes and values: Code Value 01 Low risk 02 Intermediate risk 03 High risk

6.5 Memorial Sloan-Kettering Cancer Centre Prognosis Category

Common name: Motzer Prognosis Category Definition: The prognosis category associated with the Memorial Sloan-Kettering Cancer Centre criteria used to predict survival for patients with metastatic clear cell renal cell carcinoma Format: Characters Field length: 2 Codes and values: Code Value 01 Good prognosis 02 Intermediate prognosis 03 Poor prognosis


60

Section 7. Cancer of the Renal Pelvis and Ureter

7.1 TNM Tumour Classification (Clinical) (Cancer of the Renal Pelvis and Ureter)

Common name: Clinical TNM Tumour Classification (Cancer of the Renal Pelvis and Ureter). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the size and extent of the tumour of the renal pelvis and ureter as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value

Explanatory Notes



01 TNM Classification Ta

Non-invasive papillary carcinoma.

02 TNM Classification Tis

Carcinoma in situ (CIS).


Tumour invades subepithelial connective tissue.


Tumour invades muscularis.

A Renal

Pelvis Tumour invades beyond muscularis into peripelvic fat or renal parenchyma.


B Ureter Tumour invades beyond muscularis into periureteric fat.


Tumour invades adjacent organs or through the kidney into perinephric fat.



99 Not known Related data items: TNM Nodal Classification (Clinical) (Cancer of the Renal Pelvis and Ureter) TNM Metastases Classification (Clinical) (Cancer of the Renal Pelvis and Ureter)


61

7.2 TNM Nodal Classification (Clinical) (Cancer of the Renal Pelvis and Ureter)

Common name: Clinical TNM Nodal Classification (Cancer of the Renal Pelvis and Ureter). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the renal pelvis and ureter metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Metastasis in a single lymph node 2 cm or less in greatest

dimension. 02 TNM Classification N2 Metastasis in a single lymph node more than 2 cm but not

more than 5 cm in greatest dimension, or multiple lymph nodes, none more than 5 cm in greatest dimension.

03 TNM Classification N3 Metastasis in a lymph node more than 5 cm in greatest dimension.


99 Not known Related data items: TNM Tumour Classification (Clinical) (Cancer of the Renal Pelvis and Ureter) TNM Metastases Classification (Clinical) (Cancer of the Renal Pelvis and Ureter)

7.3 TNM Metastases Classification (Clinical) (Cancer of the Renal Pelvis and Ureter)

Common name: Clinical TNM Metastases Classification (Cancer of the Renal Pelvis and Ureter). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the renal pelvis and ureter as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2


62

Codes and values: Code Value Explanatory Notes 00 TNM Classification M0 No distant metastasis. 01 TNM Classification M1 Distant metastasis. 02 TNM Classification MX Distant metastasis cannot be assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Renal Pelvis and Ureter) TNM Tumour Classification (Clinical) (Cancer of the Renal Pelvis and Ureter)


63

Section 8. Cancer of the Urinary Bladder

8.1 TNM Tumour Classification (Clinical) (Cancer of the Urinary Bladder)

Common name: Clinical TNM Tumour Classification (Cancer of the Urinary Bladder). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the size and extent of the tumour of the urinary bladder as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value

Explanatory Notes



01 TNM Classification Ta

Non-invasive papillary carcinoma.

02 TNM Classification Tis

Carcinoma in situ: “flat tumour”.


Tumour invades subepithelial connective tissue.

Tumour invades muscle. A T2a Tumour invades superficial muscle (inner half).


B T2b Tumour invades deep muscle (outer half). Tumour invades perivesical tissue. A T3a Tumour invades perivesical tissue

microscopically.


B T3b Tumour invades perivesical tissue macroscopically (extravesical mass).

Tumour invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall.

A T4a Tumour invades prostate, uterus, or vagina.


B T4b Tumour invades pelvic wall or abdominal wall. 07 TNM

Classification TX Primary tumour cannot be assessed.

99 Not known Related data items: TNM Nodal Classification (Clinical) (Cancer of the Urinary Bladder) TNM Metastases Classification (Clinical) (Cancer of the Urinary Bladder)


64

8.2 TNM Nodal Classification (Clinical) (Cancer of the Urinary Bladder)

Common name: Clinical TNM Nodal Classification (Cancer of the Urinary Bladder). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the urinary bladder metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Metastasis in a single lymph node 2 cm or less in greatest

dimension. 02 TNM Classification N2 Metastasis in a single lymph node more than 2 cm but not

more than 5 cm in greatest dimension, or multiple lymph nodes, none more than 5 cm in greatest dimension.

03 TNM Classification N3 Metastasis in a single lymph node more than 5 cm in greatest dimension.


99 Not known Related data items: TNM Tumour Classification (Clinical) (Cancer of the Urinary Bladder) TNM Metastases Classification (Clinical) (Cancer of the Urinary Bladder)

8.3 TNM Metastases Classification (Clinical) (Cancer of the Urinary Bladder)

Common name: Clinical TNM Metastases Classification (Cancer of the Urinary Bladder). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the urinary bladder as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2


65

Codes and values: Code Value Explanatory Notes 00 TNM Classification M0 No distant metastasis. 01 TNM Classification M1 Distant metastasis. 02 TNM Classification MX Distant metastasis cannot be assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Urinary Bladder) TNM Tumour Classification (Clinical) (Cancer of the Urinary Bladder)


66

Section 9. Cancer of the Urethra

9.1 TNM Tumour Classification (Clinical) (Cancer of the Urethra)

Common name: Clinical TNM Tumour Classification (Cancer of the Urethra). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the size and extent of the tumour of the urethra as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification T0 No evidence of primary tumour. 01 TNM Classification Ta Non-invasive papillary, polypoid, or verrucous carcinoma. 02 TNM Classification Tis Carcinoma in situ (CIS). 03 TNM Classification T1 Tumour invades subepithelial connective tissue. 04 TNM Classification T2 Tumour invades any of the following: corpus spongiosum,

prostate, periurethral muscle. 05 TNM Classification T3 Tumour invades any of the following: corpus cavernosum,

beyond prostatic capsule, anterior vagina, bladder neck. 06 TNM Classification T4 Tumour invades other adjacent organs. 07 TNM Classification TX Primary tumour cannot be assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Urethra) TNM Metastases Classification (Clinical) (Cancer of the Urethra)

9.2 TNM Nodal Classification (Clinical) (Cancer of the Urethra)

Common name: Clinical TNM Nodal Classification (Cancer of the Urethra). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the urethra metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters


67

Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Metastasis in a single lymph node 2 cm or less in greatest

dimension. 02 TNM Classification N2 Metastasis in a single lymph node more than 2 cm in

greatest dimension, or multiple lymph nodes. 03 TNM Classification NX Regional lymph nodes cannot be assessed (e.g.


Related data items: TNM Tumour Classification (Clinical) (Cancer of the Urethra) TNM Metastases Classification (Clinical) (Cancer of the Urethra)

9.3 TNM Metastases Classification (Clinical) (Cancer of the Urethra)

Common name: Clinical TNM Metastases Classification (Cancer of the Urethra). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the urethra as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification M0 No distant metastasis. 01 TNM Classification M1 Distant metastasis. 02 TNM Classification MX Distant metastasis cannot be assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Cancer of the Urethra) TNM Tumour Classification (Clinical) (Cancer of the Urethra)


68

Section 10. Transitional Cell Cancer of the Prostate (Prostatic Urethra)

10.1 TNM Tumour Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra))

Common name: Clinical TNM Tumour Classification (Transitional Cell Cancer of the Prostate (Prostatic Urethra)). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the size and extent of the transitional cell cancer of the prostate and prostatic urethra as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification T0 No evidence of primary tumour. 01 TNM Classification Tis pu Carcinoma in situ (CIS), involvement of prostatic

urethra. 02 TNM Classification Tis pd Carcinoma in situ (CIS), involvement of prostatic ducts. 03 TNM Classification T1 Tumour invades subepithelial connective tissue. 04 TNM Classification T2 Tumour invades any of the following: prostatic stroma,

corpus spongiosum, periurethral muscle. 05 TNM Classification T3 Tumour invades any of the following: corpus

cavernosum, beyond prostatic capsule, bladder neck (extraprostatic extension).

06 TNM Classification T4 Tumour invades other adjacent organs (invasion of bladder).

07 TNM Classification TX Primary tumour cannot be assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra)) TNM Metastases Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra))


69

10.2 TNM Nodal Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra))

Common name: Clinical TNM Nodal Classification (Transitional Cell Cancer of the Prostate (Prostatic Urethra)). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of regional lymph node of the transitional cell cancer of the prostate and prostatic urethra) metastasis as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification N0 No regional lymph node metastasis. 01 TNM Classification N1 Metastasis in a single lymph node 2 cm or less in greatest

dimension. 02 TNM Classification N2 Metastasis in a single lymph node more than 2 cm in

greatest dimension, or multiple lymph nodes. 03 TNM Classification NX Regional lymph nodes cannot be assessed (e.g.


Related data items: TNM Tumour Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra)) TNM Metastases Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra))

10.3 TNM Metastases Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra))

Common name: Clinical TNM Metastases Classification (Transitional Cell Cancer of the Prostate (Prostatic Urethra)). Main source of standard: TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, UICC, 2002). Definition: A record of the extent of metastatic spread of the tumour of the transitional cell cancer of the prostate and prostatic urethra as determined by pre-treatment investigations (not pathological), coded according to the official TNM Classification (TNM Classification of Malignant Tumours, Sixth Edition, 2002). Format: Characters


70

Field length: 2 Codes and values: Code Value Explanatory Notes 00 TNM Classification M0 No distant metastasis. 01 TNM Classification M1 Distant metastasis. 02 TNM Classification MX Distant metastasis cannot be assessed. 99 Not known

Related data items: TNM Nodal Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra)) TNM Tumour Classification (Clinical) (Transitional Cell Cancer of the Prostate (Prostatic Urethra))


71

Appendix 1 - Working Group

Membership of Urological Cancer Data Standards Working Group Name Position Organisation Graham Hollins (Chair)

Consultant Urological Surgeon NHS Ayrshire and Arran

Brian Corr Urology Clinical Nurse Specialist NHS Highland Brian McGlynn Specialist Nurse in Uro-oncology NHS Ayrshire and Arran Chris Goodman Consultant Urological Surgeon NHS Tayside Dave Stobie Data Definitions and Terminology

Officer ISD, National Services Scotland

Jean Harvey Cancer Definitions Manager ISD, National Services Scotland

Ian Smith Clinical Specialist Radiographer NHS Tayside John MacFarlane Urologist NHS Fife Lawrence Walker Urologist/ Lead Clinician NHS Lanarkshire Lorna Bruce Urology MDT Facilitator/ Urology Audit

Admin Facilitator NHS Lothian

Liz Mitchell AHP Advisor ISD, National Services Scotland

Mark Underwood MCN Chair/ Consultant Urologist NHS Greater Glasgow & Clyde (A&C)

Martin Russell Consultant in Clinical Oncology NHS Greater Glasgow & Clyde (A&C)

Michael Aitchison Urologist NHS Greater Glasgow & Clyde (A&C)

Michael Hehir Lead Clinician/ Consultant Urologist NHS Forth Valley Nick Cohen Consultant Urologist NHS Grampian Paul Cormie Lead GP Cancer & Palliative Care NHS

Borders NHS Borders

Phyllis Windsor Oncologist NHS Tayside Prasad Bollina Urologist NHS Lothian Rana Mahmood Consultant in Clinical Oncology NHS Greater Glasgow &

Clyde (A&C) Ron Alexander Lead Clinician/ Consultant Urologist NHS Greater Glasgow &

Clyde (A&C) Zareena Rafiq

Information Manager ISD, National Services Scotland


72


73

Appendix 2 - Consultation Distribution List Regional Cancer Networks – NOSCAN, SCAN, WOSCAN Allied Health Professionals British Association of Urological Surgeons Cancer e-Health (Subgroup of the Scottish Cancer Group) Clinical Data Standards Working Groups Electronic Clinical Communications Implementation ECCI programme board Generic Clinical System Project Board MacMillan Cancer National Clinical Information Steering Group (CMO) National Clinical Audit Support Group NHS Connecting for Health NHS Quality Improvement Scotland NHS Boards (through Clinical eHealth leads) Royal Colleges: The Royal College of Pathologists (Scotland); The Royal College of Radiologists (RCR Scotland); Royal Colleges – Royal College of General Practitioners (RGCP Scotland); Royal College of Physicians Edinburgh (RCPE); Royal College of Surgeons Edinburgh (RCSE); Royal College of Physicians and Surgeons of Glasgow (RCPSG); Royal College of Nursing (RCN); The Royal College of Pathologists (London). Scottish Cancer Research Network Scottish Clinical Information Management Practice (SCIMP) Scottish Pharmacy Oncology Group Scottish Pathology Network (SPAN) Cancer Research UK

Appendix 3 - Urological Cancer Proposed Changes

Ablation Energy Source Existing Proposed Change Summary Definition: A record of the type of energy source used for ablation. Format: Characters Field length: 3 Codes and values: Code Value Sub-code Sub-value

A 4 mm tip B 8 mm tip

01 Radiofrequency

C Cooled 02 Cryo 03 Ultrasound 98 Other (specify) 99 Not known

Formal Name: Ablation Energy Source Definition: A record of the type of energy source used for ablation. Format: Characters Field length: 3 Codes and values: Code Value Sub-code Sub-value

A 4 mm tip B 8 mm tip C Cooled

01 Radiofrequency

D Radiofrequency interstitial tumour (RITA)

02 Cryo 03 Ultrasound

A High-intensity focused ultrasound (HIFU)

04 Microwave 05 Radionuclide 06 Embolisation 07 Laser 08 Radiotherapy

This standard is to be revised with the addition of extra values to meet Urological Cancer requirements.

09 Electrosurgery 96 Not applicable 98 Other (specify) 99 Not known

Related data items: Treatment Modalities {Cancer} Recording guidance: Users may wish to augment code ’98 – Other (specify)’ with a free text field for recording other values of this item.


75

Surgical Procedure Type (Colorectal Cancer) Existing Proposed Change Summary Definition: The type of surgical procedure(s) performed for investigation and/or treatment of cancer. This also includes nodal and reconstructive surgery performed on the patient for treatment of cancer. Format: Characters Field length: 3 Codes and values: Code Value Sub-

code Sub-value Explanatory

Notes 01 Open

A Completed 02 Laparoscopic

B Converted

96 Not li bl

e.g. Surgery not performed.

99 Not known

Formal Name: Surgical Procedure Type (Colorectal Cancer) Definition: The type of surgical procedure(s) performed for investigation and/or treatment of cancer. This also includes nodal and reconstructive surgery performed on the patientfor treatment of cancer. Format: Characters Field length: 3 Codes and values: Code Value Sub-

codeSub-value Explanatory

Notes 01 Open

A Completed 02 Laparoscopic

B Converted

03 Pluck approach

96 Not applicable e.g. Surgery not performed.

99 Not known

This standard is to be revised by adding the value “Pluck” to meet Urological Cancer requirements and to make the standard generic.


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Type(s) of Continence Problem Identified (Bladder Continence) Existing Proposed Change Summary

Definition: A record of the type(s) of continence problem(s) identified following assessment. Format: Characters

Field Length: 2 Codes and Values: Code Value Explanatory Notes 00 No Problems Identified 01 Nocturia 02 Nocturnal Enuresis 03 Stress Urinary Incontinence 04 Urge Urinary Incontinence 05 Mixed Urinary Incontinence 06 Continuous Urinary

Incontinence

07 Over Active Bladder Syndrome

08 Functional Incontinence 09 Reflex Incontinence 10 Voiding Dysfunction 98 Other (specify) e.g. situational incontinence. 99 Not Known

Recording Guidance: Systems must allow for the recording of multiple options

Formal Name: Type(s) of Continence Problem Identified (Bladder Continence)

Definition: A record of the type(s) of continence problem(s) identified following assessment. Format: Characters

Field length: 2 Codes and Values: Code Value Explanatory Notes 00 No Problems Identified 01 Nocturia 02 Nocturnal Enuresis 03 Stress Urinary Incontinence 04 Urge Urinary Incontinence 05 Mixed Urinary Incontinence 06 Continuous Urinary

Incontinence

07 Over Active Bladder Syndrome

08 Functional Incontinence 09 Reflex Incontinence 10 Voiding Dysfunction 11 Overflow incontinence 98 Other (specify) e.g. situational incontinence. 99 Not Known

Recording Guidance:

This standard is to be revised by adding the value “Overflow incontinence” to meet Urological Cancer requirements.


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Users may wish to augment code 98 – “Other (specify)”

with a free text field for recording other types of continence problems identified.

Systems must allow for the recording of multiple options

Users may wish to augment code 98 – “Other (specify)” with a free text field for recording other types of continence problems identified.


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Treatment modalities {Cancer} Existing Proposed Change Summary

Definition: The specific treatment modality administered to a patient. Format: 2 characters Codes and values: Code Value 01 Surgery 02 External Beam Radiotherapy 03 Brachytherapy 04 Radioactive unsealed source therapy 05 Chemotherapy 06 Biological therapy 07 Hormone therapy 08 Watchful waiting 09 Supportive care 10 Other therapy 11 Patient declined all therapies 12 Patient died before treatment 99 Not known

Further information: The purpose of this standard is to enable the user to navigate the clinical system.

Formal name: Treatment Modalities {Cancer} (Cancer) Definition: The specific treatment modality administered to a patient. Format: 2 characters Codes and values: Code Value 01 Surgery 02 External Beam Radiotherapy 03 Brachytherapy 04 Radioactive unsealed source therapy 05 Chemotherapy 06 Biological therapy 07 Hormone therapy 08 Watchful waiting 09 Supportive care 10 Other therapy 11 Patient declined all therapies 12 Patient died before treatment 13 Active surveillance 99 Not known

Further information: The purpose of this standard is to enable the user to navigate the clinical system.

This standard is to be revised by adding the value “Active surveillance”to meet Urological Cancer requirements.


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Combined treatments may be administered concurrently e.g. chemotherapy and radiotherapy, intra-operative chemotherapy, intra-operative radiotherapy. Each treatment modality should be recorded separately and the combined treatment can be determined by treatment dates and/or codes and values. Recording guidance: This item may occur more than once throughout a patient’s record.

Combined treatments may be administered concurrently e.g. chemotherapy and radiotherapy, intra-operative chemotherapy, intra-operative radiotherapy. Each treatment modality should be recorded separately and the combined treatment can be determined by treatment dates and/or codes and values. Recording guidance: This item may occur more than once throughout a patient’s record.


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Chemotherapy Line Number Existing Proposed Change Summary Common name: Chemotherapy Course Number Definition: The chronological line number of a chemotherapy regimen. Format: Characters Field length: 2 Codes and values:

Code Value Explanatory Notes 01 First line Includes neo-adjuvant and

adjuvant. 02 Second line 03 Third line 04 Fourth line 05 Fifth line 96 Not applicable E.g. no chemotherapy given. 98 Other (specify) 99 Not known

Related data items: Treatment Status {Cancer} Reason Treatment Not Delivered {Cancer} Date Treatment Started {Cancer} Date Treatment Completed {Cancer}

Formal: Systemic Therapy Line Number Common name: Chemotherapy Course Number Definition: The chronological line number of a chemotherapy regimen. Format: Characters Field length: 2 Codes and values:

Code Value Explanatory Notes 01 First line Includes neo-adjuvant and adjuvant.02 Second line 03 Third line 04 Fourth line 05 Fifth line 96 Not applicable E.g. no chemotherapy given. 98 Other (specify) 99 Not known

Related data items: Treatment Status {Cancer} Reason Treatment Not Delivered {Cancer} Date Treatment Started {Cancer} Date Treatment Completed {Cancer} Chemotherapy Type {Cancer}

This standard is to be revised to meet Urological Cancer requirements. This will allow the line number to be recorded for other systemic treatments.


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Chemotherapy Type {Cancer} Side Effects (Chemotherapy) Chemotherapy Total Number of Cycles Administered {Cancer} Recording guidance: Users may wish to augment code ‘98 – Other (specify)’ with a free text field for recording other values of this item.

Side Effects (Chemotherapy) Chemotherapy Total Number of Cycles Administered {Cancer} Recording guidance: Users may wish to augment code ‘98 – Other (specify)’ with a free text field for recording other values of this item.

urological clinical cancer data standards cancer clinical data... · the scottish cancer group...

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