Colorectal PolypColorectal NeoplasmsColorectal AdenomaColorectal CancerDigestive System Disease
Investigational drug(s) / intervention(s)
FITColonoscopy
FIT: Annual FIT
Colonoscopy: One time surveillance colonoscopy
Study summary
This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.
Eligibility
Sex
ALL
Min age
65 Years
Max age
82 Years
Healthy volunteers
No
Inclusion Criteria:
* English or Spanish speaking
* Personal history of colorectal polyps
* Most recent colonoscopy with ≤2 non-advanced polyps
* Currently due or coming due within 12 months for colonoscopy
* Able to provide written informed consent
Exclusion Criteria:
* Personal history of colorectal cancer
* Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome)
* Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)
* Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps
* Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year)
* Patients unable to provide written informed consent
Primary outcome measure(s)
Incidence of advanced neoplasia in each study group, annual FIT and colonoscopy, assessed by comparing the detection of advanced neoplasia between the two study groups. — Up to 11 years The investigators will determine the incidence of advanced neoplasia, defined as adenocarcinoma of the colon or rectum or adenomas or serrated polyps ≥1 cm in size or with villous features or any dysplasia, or traditional serrated polyps, in both study groups through annual surveys asking about any changes in polyp history or new cancer diagnosis for up to 6 years and medical record review for up to 11 years. The incidence of advanced neoplasia will be compared between the two study group cumulatively after all the data has been collected.
Trial sites (24)
Facility
City
Region
Status
University of Alabama Birmingham
Birmingham
Alabama
Active Not Recruiting
University of Arizona
Tucson
Arizona
Recruiting
Jennifer Moreno Department of Veterans Affairs Medical Cneter
San Diego
California
Recruiting
Kaiser Permanente Northern California
Walnut Creek
California
Recruiting
University of Colorado
Aurora
Colorado
Recruiting
MedStar Health
Washington D.C.
District of Columbia
Recruiting
James A. Haley Veterans Hospital
Tampa
Florida
Recruiting
Northwestern Memorial Hospital
Chicago
Illinois
Recruiting
Richard L. Roudebush VA Medical Center
Indianapolis
Indiana
Recruiting
University of Michigan Health
Ann Arbor
Michigan
Recruiting
Henry Ford
Detroit
Michigan
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
Dartmouth Health
Lebanon
New Hampshire
Recruiting
New York Harbor Health Care System - Dept of Veterans Affairs
New York
New York
Recruiting
Wake Forest University Health Sciences
Charlotte
North Carolina
Recruiting
Kaiser Permanente Northwest
Portand
Oregon
Active Not Recruiting
Oregon Health & Science University (Knight Cancer Institute)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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