update on the confirm study - world endo

Update on the CONFIRM Study Colonoscopy versus Fecal Immunochemical Test

in Reducing Mortality from Colorectal Cancer

Jason A. Dominitz, MD, MHS

CONFIRM Co-Chairs

Jason Dominitz, MD, MHS National GI Program Director

Department of Veterans Affairs VA Puget Sound HCS

Professor of Medicine University of Washington

Seattle, WA

Douglas J. Robertson, MD, MPH GI Section Chief

VA Medical Center White River Junction, Vermont

Professor of Medicine Geisel School of Medicine at

Dartmouth & The Dartmouth Institute

Hanover, New Hampshire

Primary Aim

To determine if a strategy of screening colonoscopy decreases CRC mortality over 10 years in average

risk adults as compared to annual FIT screening

Secondary Aims 1. To determine if a screening colonoscopy decreases 10 year CRC incidence as

compared to annual FIT screening

2. To evaluate the safety of screening colonoscopy

3. To evaluate the association between colonoscopists’ characteristics and the initial detection of colorectal neoplasia, complications and post-colonoscopy CRC

Dominitz and Robertson et al. Am J Gastroenterol 2017;112:1736-46

Recruit 50,000‘screen eligible’ Veterans (Age 50-75)

Randomize

Screening

Colonoscopy

Annual FIT

Test

FIT Test

Positive?

10th Year of

Follow-

Up?

Evaluation by Site

PI for further

Follow-up

Follow-up for outcomes over 10+ years

CRC Mortality (Primary Outcome)

CRC Incidence (Secondary Outcome)

Yes

No

No

Yes


Seattle, WA

White River Jct., VT Portland, OR

San Diego, CA

Loma Linda, CA

Phoenix, AZ

Denver, CO

Ann Arbor, MI

Minneapolis, MN

Houston, TX

Dallas, TX

Boston, MA Providence, RI

Northport, NY

Cleveland, OH

Clarksburg, WV

Durham, NC

Gainesville, FL

Indianapolis, IN

Kansas City, MO

Memphis, TN Los Angeles, CA

Fresno, CA

Salt Lake City, UT

Oklahoma City, OK

St. Louis, MO

Detroit, MI Madison, WI

Chicago, IL

Miami, FL

Tampa, FL

Richmond, VA

Philadelphia, PA Baltimore, MD

Long Beach, CA

Atlanta, GA

West Haven, CT

CSP #577 CONFIRM Study Sites

Orlando, FL

San Juan, PR

Salisbury, NC

Honolulu, HI

Little Rock, AR

East Orange, NJ

Washington, DC

Manchester, NH


Louisville, KY

Study Participants-Age Distribution N=50,126

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

50-55 55-<60 60-<65 65-<70 70-75

Nu

mb

er o

f Pa

rtic

ipan

ts

Age Group

34%

18%

21% 20%

7%

Mean Age = 59.1 years

Study Participants-Gender N=50,126

Male 93%

Female 7%

Study Participants-Race and Ethnicity N=50,126

White 72%

Black 25%

Native American [PERCENTAGE] Non-

Hispanic/Latino, 88%

Puerto Rican, 4%

Other Hispanic/Latino, [PERCENTAGE]

Mexican, 3%

Cuban, 1%

Study Flow Chart and Colonoscopy Findings

Adenoma Detection Rate = 45.7% Advanced Adenoma Detection = 9.4% Sessile Serrated Lesion Detection = 3.7%

Multivariable Predictors of Adenoma Detection: 1/3

Predictors of Advanced Adenomas and Sessile Serrated Polyps

• Please come to our poster on Monday!

Name of presenter

Adverse Events (N=523)

Type Count

Blood per rectum 182

Abdominal pain 62

Proctalgia 11

Mild 491 84%

Moderate 88

15%

Severe 6

1% Most Common Adverse Events by Type

N=528 total events

Adverse Events (N=523)

Mild 491 84%

Moderate 88

15%

Severe 6

1%

N=528 total events

Type Count

Prep related severe nausea and vomiting

2 cancelled procedure 1 never completed procedure

3

Abdominal pain requiring ER visit 2

Severe cramping, bleeding and chest pain post-procedure

1

Severe AE (n=6)

Serious Adverse Events

Experienced SAE

N=235 (1.3%)

Not Related

N=148 Possibly Related

N=38 Definitely Related

N=52

SAE Type Count

Serious Bleeding 31 (0.18 %)

Cardiovascular Events 31 (0.18%)

“Perforations” 5 (0.03%)

Study

Colonoscopy

N=17,485

“Perforations” (n=5) Age/

Gender Race Endoscopist

(Fellow) Polypectomy Attribution Surgery Description

A 65/M White GI (No) No Yes Left colectomy

Sigmoid perf at time of study colonoscopy & to immediate surgery

B 68/M White Missing (No) No Yes Open Sigmoid

resection

Sigmoid perforation at time of study colonoscopy & to immediate surgery

C 51/M White GI (No) No Possibly Lap Sigmoid

Resection

Diverticulitis 7 days after procedure complicated by abscess requiring IR

drainage and surgery

D 55/M AA GI (Yes) Yes Yes No Immediately hypotensive and diaphoretic after large polyp removal.

No evidence of pneumoperitoneum on CT, but mild fluid collection ascending

colon.

E 67/M White GI (Yes) Yes Yes No Severe post-procedure pain developing 24-48 hours after colonoscopy; FA on

KUB; pneumatosis on CT

Risk Factors for Serious Adverse Events

±

±

±

CONFIRM Biorepository

• Blood for DNA and RNA

• Storage of FIT kits

• Access to pathology specimens

• 10,703 enrolled in the biorepository

Name of presenter

Summary 1) CONFIRM randomized 50,126 average risk adults to screening colonoscopy vs.

FIT and is following for 10+ years for cancer outcomes

2) Adenomas were found in 45.7% of Veterans undergoing screening colonoscopy

(far exceeding the benchmark adenoma detection rate)

3) Our study confirms the importance of several demographic and environmental

risk factors for adenomas, AA and sessile serrated lesions

4) AE and SAE related to colonoscopy occur in approximately 3.0% and 0.5% of

colonoscopies, respectively

5) Polypectomy is an independent predictor of SAE’e

6) We anticipate many more analyses from this prospective cohort and

biorepository

CONFIRM Study Team Study Co-Chairs

Jason A. Dominitz, MD, MHS, Seattle. WA Douglas J. Robertson, MD, MPH, White River Junction, VT

National Chairs’ Offices

Meaghan Larson, MPH, National Coordinator, Seattle, WA Andrew LaCasse, National Coordinator, White River Junction, VT

West Haven CSP Coordinating Center

Tassos Kyriakides, PhD Director Alex Beed, MS, Study Biostatistician

Lynn Tommessilli, Study Project Manager

Albuquerque Pharmacy Coordinating Center

Kathy Boardman, RPh, Study Pharmacist

Barbara Del Curto, Project Manager

Other Executive Committee Members

Dennis Ahnen, MD, Denver, CO

Tom Imperiale, MD, Indianapolis, IN

David Lieberman, MD, Portland, OR

Dawn Provenzale, MD, MS, Durham, NC

Shahnaz Sultan, MD, Minneapolis, MN

Aasma Shaukat, MD, Minneapolis, MN

Local Site Investigators - Present • Aasma Shaukat, MD, MPH

• Adnan Said, MD, MS

• Amelia (Beth) Underwood, MD

• Andrew J. Gawron, MD

• Andrew M. Kaz, MD

• Charles H. Beymer, MD, MPH

• Charles Kahi, MD

• Christian S. Jackson, MD

• Christopher Lenza, DO

• Claudio Tombazzi, MD

• Curt H. Hagedorn, MD

• David Lieberman, MD

• Deborah A. Fisher, MD, MHS

• Deepak Desai, MD

• Devang Prajapati, MD

• Deborah A. Fisher, MD, MHS

• Deepak Desai, MD

• Devang Prajapati, MD

• Dipendra Parajuli, MD

• Doris H. Toro, MD

• Douglas J. Nguyen, MD

• E. Carter Paulson, MD

• Edward Sun, MD

• Endashaw Omer, MD, MPH

• Eric K. Taylor, NP

• Erik C. von Rosenvinge, MD

• Fadi Antaki, MD

• Folasade P. May, MD, MPhil, PhD

• Frank S. Pancotto, MD

• Gyorgy Baffy, MD, PhD

• Heather Hockman, MD

• Heiko Pohl, MD

• Helen W. Wong, MD

• Ildiko Halasz, MD

• Jed E. Olson, MD

• Jeffrey A. Gill, MD

Local Site Investigators - Present • Jill E. Elwing, MD

• Joseph Manlolo, MD

• Joseph R. Pisegna, MD

• Katarina B. Greer, MD, MS

• Kerry Dunbar, MD

• Kittichai Promrat, MD

• Lyn Sue Kahng, MD

• Margaret F. Kinnard, MD

• Michael Yao, MD

• Michele Young, MD

• Mitchell Schubert, MD

• Mohammad Madhoun, MD

• Nancy C. Ho, MD

• Paul A. Feldman, MD, MSC

• Petr Protiva, MD

• Prateek Sharma, MD

• Priscilla Magno, MD

• Rebecca J. Beyth, MD, MSc

• Rhonda A. Cole, MD

• Riaz Cassim, MD

• Robert H. Lee, MD, MAS

• Ronald Fernando, MD

• Sameer Saini, MD, MS

• Samir Gupta, MD, MSCS

• Samuel B. Ho, MD

• Stacy Menees, MD

• Stephan Goebel, MD

• Swati G. Patel, MD

• Tarun Rai, MD

• Thomas F. Imperiale, MD

• William M. Tierney, MD

• William V. Harford, Jr. MD

Local Site Investigators - Past •Christopher Lopez, MD

•Dennis J. Ahnen, MD

•Farrukh H. Merchant, MD

•Fernando V. Ona, MD

• Isabelita Cordoba Rellosa, MD

• J. Andy Mengshol, MD, PhD

• Juan Diego Baltodano, MD

•Kenneth H. Berman, MD

•Lubna Maruf, MD

•M. Mazen Jamal, MD, MPH

•Mae F. Go, MD

•Marcos C. Pedrosa, MD, MPH

•Martin Tobi, MB, ChB

•Mohammad Wehbi, MD

•Phillip Schoenfeld, MD, MSEd, MSc

•Ranjan C.V. Mascarenhas, MD

•Robert D. Shaw, MD

•Shahnaz Sultan, MD, MHSc

•Steven R. Warlick, MD

•Susan Goldsmith, MD

•Toan D. Nguyen, MD

Acknowledgements

CONFIRM is funded and being conducted by the Cooperative Studies Program

Office of Research and Development

Department of Veterans Affairs

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