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Colonoscopy vs FIT Screening for Colorectal Cancer (CONFIRM Trial)

N/A
Waitlist Available
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female adults aged 50-75 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

CONFIRM Trial Summary

This trial will compare the effectiveness of two ways to screen for colorectal cancer: colonoscopy (invasive, expensive, requires prep) and fecal immunochemical testing (FIT, non-invasive, inexpensive, no prep).

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Colonoscopy may cause complications like bleeding or tears in the colon wall; however these are rare. FIT involves collecting stool samples at home and has no direct side effects but may lead to further testing if results are positive.

CONFIRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 50 and 75 years old.

CONFIRM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The is colorectal cancer mortality.
Secondary outcome measures
FIT Positive - If Colonoscopy is Warranted

CONFIRM Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
FIT (annually)
Group II: Arm 1Experimental Treatment1 Intervention
Colonoscopy (one time screening)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FIT
2022
Completed Phase 2
~13520
Colonoscopy
2012
Completed Phase 3
~115560

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,273,280 Total Patients Enrolled
Jason A. Dominitz, MD MHSStudy ChairVA Puget Sound Health Care System Seattle Division, Seattle, WA
Douglas J Robertson, MD MPHStudy ChairWhite River Junction VA Medical Center, White River Junction, VT

Media Library

Colonoscopy Clinical Trial Eligibility Overview. Trial Name: NCT01239082 — N/A
Colorectal Cancer Research Study Groups: Arm 2, Arm 1
Colorectal Cancer Clinical Trial 2023: Colonoscopy Highlights & Side Effects. Trial Name: NCT01239082 — N/A
Colonoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01239082 — N/A
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT01239082 — N/A
~13350 spots leftby Dec 2028
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