FlorCDC HPV TyCDC HPV Ty

State of Florida DFlorida Canc

U i itUniversity

PresenPresenDr. Jill M

CarlosAmy

ridayping Studyyping Study

epartment of Healthcer Data System

f Fl idy of Florida

nted by:nted by:MacKinnons AlvarezWright

CDC HPV T

CDC pilot study protocol Hp y pIntrod

The Centers for Disease Control and Pti i t i il t j t t d tparticipate in a pilot project to deter

systematic approach to monitoring humseveral different HPV related cancers selected head and neck cancers). This randomly selected cancer diagnosed in(through their coordinating center Batt(through their coordinating center Batt

with processing and sh

Typing Study

HPV vaccine on HPV types

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ypductionPrevention (CDC) has chosen Florida to

i th f ibilit f d l irmine the feasibility of developing a man papilloma virus (HPV)genotypes in (cervix, vagina, vulva, penis, anus and study will involve pathology review of n your facility in 2004 and 2005. CDC telle) will cover all the costs associatedtelle) will cover all the costs associated hipping the specimens.

CDC HPV T

Florida Cancer Data Sy

Department of HealthDepartment of Health Dr. Youjie Huang, Section Admini

FCDS/U i i f Mi iFCDS/University of MiamiDr. Jill MacKinnon, EpidemiologiGary M. Levin, CTR, AdministratMegsys Herna, BA, CTR, ManageCarlos Alvarez, BBA, Field Coord

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ystem Project Team

istrator

ist and Project Directortive Directorer of Data Acquisitiondinator

CDC HPV T

Florida CentFlorida Cent

University of FloridaUniversity of Florida Dr. Ed Wilkinson, PathologiCynthia Bevis, Business ManDr. Martha Campbell ThomAmy Wright, Study DirectorKaren Hyde, Study Coordin

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tral Laboratory

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tral Laboratory

stnager

mpson, Path Lab Directorr

nator

CDC HPV TFlorida State Faci

(52 - RandomHospital/Laboratory Hospital/Laboratory Hospital/Labora

SHANDS UNIVERSITY OF FLORIDA CORAL SPRINGS MEDICAL CENTER HOMESTEAD HOS

WESTSIDE REGIONAL MED CTR CLEVELAND CLINIC HOSPITAL BAPTIST HOSPITALMEMORIAL REGIONAL HSPITAL SOUTH PLANTATION GENERAL HOSP MERCY HOSPITAL

NORTH RIDGE MEDICAL CENTER NORTHWEST MEDICAL CENTER UNIVERSITY OF MBROWARD GENERAL MEDICALBROWARD GENERAL MEDICAL CENTER FLORIDA MEDICAL CENTER DOCTORS HOSPITA

MEMORIAL REGIONAL CANCER CENTER/ONCOLOGY DATA CTR MEMORIAL SUPPORT SERVICES UNIVERSITY MEDICAL CENTER HIALEAH HOSPITANORTH BROWARDMEDICALNORTH BROWARD MEDICAL CENTER MEMORIAL HOSPITAL WEST MIAMI HEART INS

IMPERIAL POINT MEDICAL CENTERJACKSON SOUTH COMMUNITY CENTER MOUNT SINAI ME

MEMORIAL HOSPITAL PEMBROKEAVENTURA HOSP AND COMP CANCER CTR NORTH SHORE MEJAMES M JACKSON MEMORIAL

HOLY CROSS HOSPITALJAMES M JACKSON MEMORIAL HOSPITAL PALM SPRINGS GE

Typing Studyyp g yility Participants

mly Selected)atory Hospital/Laboratory Hospital/Laboratory

PITALMETROPOLITAN HOSPITAL OF MIAMI COLUMBIA HOSPITALCORE PLUS LLC at KENDALL 

L OF MIAMI MEDICAL CENTER DELRAY MEDICAL CENTERSOUTH SHORE HOSPITAL & MEDICAL CTR BETHESDA MEMORIAL HOSPITAL

IAMI HOSPITAL U OF MIAMI HOSPITAL CLINICS ST MARYS HOSPITAL

AL JACKSON NORTH MEDICAL CENTER WEST BOCA MEDICAL CENTER

AL SOUTH MIAMI HOSPITALBOCA RATON COMMUNITY HOSPITALGOOD SAMARITANMEDICAL

TITUE CORAL GABLES HOSPITALGOOD SAMARITAN MEDICAL CENTER

DICAL CENTER PALMETTO GENERAL HOSPITAL JFK MEDICAL CENTER

EDICAL CENTER H LEE MOFFITT CANCER CENTERWELLINGTON REGIONAL MEDICAL CENTER

ENERAL HOSPITAL LEE MEMORIAL HEALTH SYSTEM PALMS WEST HOSPITAL

CDC HPV T

1 2 3

SITES SE1 

Cervical2

Vagina3

Vulva An

176 32 44 4

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4 5 6

ELECTED 4nus

5Penis

6Head/Neck Total

44 50 224 570

CDC HPV TFull Study Title:

Monitoring the Impact of a ProMonitoring the Impact of a ProTypes in Cervical and Other HTissues from Central Cancer R

Study Objective: To de elop an infrastr ct re fo To develop an infrastructure fo

types in cervical cancer cases Use the infrastructure to condu

all or a sample of cervical cancecases (penile, vulvar, vaginal, anstatesstates

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ophylactic HPV Vaccine on HPV

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ophylactic HPV Vaccine on HPV PV-associated Cancers: Using

Registries

or the s stematic monitoring of HPVor the systematic monitoring of HPV

uct a pilot study on HPV typing on p y yp ger, and other HPV-associated cancer nal, and oropharyngeal) from 4

CDC HPV T

Project Team:CDCCDC

Batte

Florida

Kentucky

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C

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C

elle

Michigan

Louisiana

CDC HPV Typin

State Cancer Registry (CRidentify eligible cases whi

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identify eligible cases, whiof cervix and other HPV-a

Send requests to pathologyto CDC A randomly geneto CDC. A randomly geneidentify each subject

ng Study Protocol

R) search cancer records, ch would be cancers with a site

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ch would be cancers with a site associated sites.

y labs to submit tissue samples erated ID will be used toerated ID will be used to

CDC HPV Typin

The CR ID will serve as trecords and the pilot stud

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records and the pilot studID and case identifier infparticipating hospitals/laparticipating hospitals/lasubmission (i.e., Tissue SForm). CR will also sendQA/QC purposes and forkits and shipping materi

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the link to the case data dy Specimen ID The list (CR

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dy Specimen ID. The list (CR fo) will be sent to the abs for the tissue sampleabs for the tissue sample Sample Request Form – White d the CR IDs to Battelle for r preparing sample collection als.

CRCentral Registryg y

White Form

CDCCDC Cancer/HPVSurveillance

SSystemTissue

Sample Request p qForm/List

CDC HPV Typin

Tissue sample submission

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The local hospital/path lath C t l P th L b t ththe Central Path Lab at ththe CPL will prepare andsample to CDC The remasample to CDC. The remareturned to the local hosp

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ab will ship the tissue block to h U i it f Fl id dhe University of Florida and ship the requested tissue aining tissue block will beaining tissue block will be

pital/path lab.

CDC HPV Typin

Pathology labs prepare tissslides using standardized p

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slides using standardized pcontamination. Samples arand Specimen ID. The laband Specimen ID. The lab HPV Lab. The linkage doclocal hospital/path lab. TheForm of SOP 102) only conspecimen IDs. The CPL, B

id tifi i f tiany identifier information.

ng Study Protocol

sue sections and H&E stained protocol to minimize

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protocol to minimize re de-identified by using CR ID submits these samples to CDCsubmits these samples to CDC

cuments are maintained by the e shipping reports (i.e., Yellow ntain anonymous CR ID and/or attelle, and CDC will not have .

SOP 102Tissue Samples Collection, p ,Preparation, Shipping, and

ReportingFor Hospitals/LabsFor Hospitals/Labs

Submitting Tissue Blocks to a Central Path Lab

CDC HPV Typin

Battelle will provide samplthe de identified tissue sam

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the de-identified tissue samcross check shipping reporHPV lab), ensure sample sHPV lab), ensure sample sprovide technical assistanchospitals/path labs as need

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le collection supplies, monitor mples’ shipment status (e g

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mples’ shipment status (e.g., rts from hospitals and CDC afe delivery and receipt, andafe delivery and receipt, and

ce to CRs and participating ded.

CDC HPV Typin

FCDS will prepare the de-iprotocol (e g CR ID demo

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protocol (e.g., CR ID, demothe de-identified data file totransfer protocol. p

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dentified data file per study ographic data etc ) and send

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ographic data, etc.) and send o Battelle via secure file

CDC HPV Typing

CDC HPV Lab confirms rl l ( PCRsample analyses (e.g., PCR

and viral load status, etc.)B tt ll i fil tBattelle via secure file traresults will not alter any tcases as it is a retrospectivcases as it is a retrospectivcases already have undergsubmission method will resubmission method will rea consistent and clean for

g Study Protocol

receipt of samples, conducts R t i HPV i tR genotyping, HPV variant ), and send the results to

f t l Th l bnsfer protocol. The lab treatment of the cancer ve analysis and the cancerve analysis and the cancer gone treatment. The file equire data to be received inequire data to be received in mat.

CDC HPV Typin

Battelle collates and mergeBattelle will run additional

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Battelle will run additionalto ensure that cancer casesgenotyping results from CDgenotyping results from CD

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es databases (from all CRs). l quality assurance programs

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l quality assurance programs s data from CR’s and DC are consistent and clean.DC are consistent and clean.

CDC HPV T

Procedures for the Path Lab: 3

1. Locate & Retrieve subject’s tissu2. Prepare tissue sample per SOP.3 Ship & Report tissue sample per3. Ship & Report tissue sample per

All supplies (except a few small itemwill be provided by Battelle. All sam

References:

p ywill also be pre-labeled by Battelle.

References: SOP 102: Tissue Samples Collecti

for Hospitals/Labs Subm

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3-Step Approach

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ue sample per CR request.

r SOPr SOP.

ms), shipping cost and materials mple containers (tubes and slides) p ( )

ion, Preparation, Shipping, and Reporting mitting Tissue Blocks to a Central Path Lab

CDCG FGreen Form

Cancer/HPVSurveillance

SystemSpecimenSpecimen

ChainOf

C dCustodyRecord

CDC HPV Tyy

Standard Operating Procedures for hoblocks to a central path lab at Universblocks to a central path lab at UniversTyping pilot study.

The tissue block will be shipped in the cowill provide a zip-lock bag for each subjeID l b l h i l k b ThID label on each zip-lock bag. The cancerRequest Form with a CR ID assigned to ewith the correct CR ID Label for each box/cassette in the zip-lock bag Use onebox/cassette in the zip-lock bag. Use one sample.

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spitals and path labs submitting tissue ity of Florida for the proposed HPVity of Florida for the proposed HPV

ontainer provided by Battelle. Battelle ect’s tissue sample. There will be a CR

i t ill d Ti S lr registry will send you a Tissue Sample each subject. Please use the zip-lock bag subject. Put the tissue block sample zip-lock bag for one subject’s tissuezip-lock bag for one subject s tissue

CDC HPV Tyy

6 2 Tissue Block Submission and Reporting:

Yellow Form6.2 Tissue Block Submission and Reporting:

6.2.3 Please record the subject’s CR IDTissue Block Submission Form (Y

6.2.4 Please check the box (Yes or No)available. If not all samples are sulocate the sample), please record Block Submission Form.

6.2.5 Please check the box to indicate t Cervix Anal P il Penile Vaginal Vulvar H&N HPV (He(

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D (per Tissue Sample Request Form) on the Yellow Form). to indicate if the subject’s tissue sample is ubmitted (e.g., inadequate sample or cannot the CR ID and check No on the Tissue

the site of the tissue sample.

ead and Neck – HPV associated sites))

CDC HPV TyyYellow Form

6.2.6 Please provide diagnosis remarks and are submitting H&N sample, pleaserecord the date and time of shipping thSubmission Form.** Use the top (1st) signature block. Thcentral path lab use when they return t

6.2.7 Make a copy of the Tissue Block Submoriginal with the tissue sample(s) to th

6.2.8 Sending Shipping Records to BattelleSubmission Form to Battelle (919-544

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submission remarks if applicable. If you e specify the actual site in remarks. Please he samples, print, and sign the Tissue Block

he lower (2nd) signature block is for the the tissue block.

mission Form for your own file and send the he central path lab.

: Please fax a copy of the Tissue Block 4-0830, Attention: Natalie Madero).

CDC HPV TyyShipments:

6.3 Shipments should be made on Mondashipment will arrive during a regular work darrive on a Federal holiday. If you are not sucoordinator : Amy Wright, ajwright@patholo

Please e-mail the central path lab coordinatoM d N@b tt ll ) th hi i dMaderoN@battelle.org) on the shipping dayensure that someone will be there to receive

6 5 Central Path Lab Returning the Tissue B6.5 Central Path Lab Returning the Tissue Bprocessed and submitted to CDC, the centralto its original hospital/path lab.

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ay through Wednesday to ensure that the day. Avoid shipping samples that may ure, please contact the central path lab’s ogy.ufl.edu , phone 352-273-7755.

or and cc Battelle Team (Natalie Madero: t i th h d d ty to give them a heads up and to the samples.

Blocks: Once the tissue sample isBlocks: Once the tissue sample is l path lab will return the tissue block

CDC HPV Tyyyping Studyyp g y

CDC HPV Tyyyping Studyyp g y

CDC HPV Tyy

Questions Florida Project Team

Youjie Huang, MD, DrPH, MPH, Section AdministrJill MacKinnon, PhD, CTR, Epidemiologist and Pro

JMacKin@med miami eduJMacKin@med.miami.eduGary M. Levin, BA, CTR, Administrative Director, 3Megsys Herna, BA, CTR, Manager of Data AcquisitCarlos Alvarez BBA Field Coordinator 305-243-26Carlos Alvarez, BBA, Field Coordinator, 305-243-26Amy Wright, MS, GLP Study Coordinator/Sr. Bioloajwright@pathology.ufl.eduMartha Campbell-Thompson, DVM PhD, MPC Dir

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& AnswersContact Information

rator: 850-245-4407, Youjie_Huang@doh.state.fl.usoject Director, 305-243-3426,

305-243-4073, GLevin@med.miami.edution, 305-243-2625, megsys_casuso@miami.edu638 calvarez2@med miami edu638, calvarez2@med.miami.eduogical Scientist: 352-273-7755,

rector: 352-273-6129, thompmc@pathology.ufl.edu

UF Laboratory Co

Molecular PatholBox 100275, RooDept. of Pathologp gand Laboratory MUniversity of Floy1600 SW ArcherGainesville, FL,Ph: 352-273-774Fax: 352-273-77molecular@patholo

ontact Information

logy Coregyom D11-41gy, Immunologygy, gyMedicineoridar Road32610-0275

4953

ogy.ufl.edu