Status:
ACTIVE_NOT_RECRUITING
Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Colorectal Cancer
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Colorectal cancer (CRC) is currently the second most common cause of cancer death in the United States, and one of the most preventable cancers. It has been shown in several randomized controlled tria...
Eligibility Criteria
Inclusion
- Male and female adults aged 50-75 years of age
- Veteran
- Able to provide informed consent
Exclusion
- Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation, including:
- More than one episode of rectal bleeding within the past 6 months
- Documented iron deficiency anemia
- Significant documented unintentional weight loss (\>10% of baseline weight) over 6 months
- Family history of CRC in a first degree relative at any age
- Prior history of colonic disease including:
- Inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease)
- One or more colorectal neoplastic polyps (i.e. adenomas)
- Colorectal cancer
- Prior history of colonic resection
- Prior colonic examination, including:
- Colonoscopy within the past 9.5 years
- Sigmoidoscopy within the past 5 years
- Barium enema within the past 5 years
- CT colonography within the past 5 years
- gFOBT or FIT in the past 10 months
- Stool DNA test within the past 3 years
- Pregnancy
- Prisoner
- Significant comorbidity that would preclude benefit from screening or pose significant risk for the performance of colonoscopy (e.g. severe lung disease, end-stage renal disease, end-stage liver disease, severe heart failure, recent diagnosis of cancer (with the exception of non-melanoma skin cancer))
- 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.
- Likely inability to track the individual over time (e.g. no permanent address at the time of screening for study entry)
Key Trial Info
Start Date :
April 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
50126 Patients enrolled
Trial Details
Trial ID
NCT01239082
Start Date
April 30 2012
End Date
December 1 2028
Last Update
November 10 2025
Active Locations (46)
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1
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
2
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
3
VA Central California Health Care System, Fresno, CA
Fresno, California, United States, 93703
4
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357