Colonoscopy vs FIT Screening for Colorectal Cancer

(CONFIRM Trial)

Recruiting in Palo Alto (17 mi)

+45 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two methods for colorectal cancer screening in people aged 50-75. One method uses a camera to find and remove precancerous growths, while the other checks for hidden blood in stool. The study aims to see which method better reduces cancer deaths over time.

Research Team

Jason A. Dominitz, MD MHS

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Douglas J Robertson, MD MPH

Principal Investigator

White River Junction VA Medical Center, White River Junction, VT

Eligibility Criteria

This trial is for men and women aged 50-75, preferably veterans, who can consent to the study. It's not for those with severe health issues that make screening risky or unnecessary, pregnant individuals, people without a stable address, or anyone with a recent history of colon disease or tests.

Inclusion Criteria

Veteran

Able to provide informed consent

I am between 50 and 75 years old.

Exclusion Criteria

I have a history of colon issues like IBD, polyps, cancer, or surgery.

Prisoner

Participation in a concurrent interventional study pertaining to the colon or rectum (including studies of colonoscopy or colorectal cancer screening. Waivers to this exclusion criteria can be requested and granted with the approval of the CONFIRM study co-chairs, the Cooperative Study Program and the leadership of the other study

Treatment Details

Interventions

• Colonoscopy (Procedure)
• FIT (Procedure)

Trial Overview The CONFIRM trial is comparing two colorectal cancer screening methods: annual fecal immunochemical tests (FIT) and colonoscopy. The goal is to see which method better reduces death from this cancer over ten years in people at average risk.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

FIT (annually)

Group II: Arm 1 Experimental Treatment 1 Intervention

Colonoscopy (one time screening)

Colonoscopy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Japan as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in China as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Switzerland as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine