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Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

NCT05612347 · Dartmouth-Hitchcock Medical Center
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Official title
Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps
About this study
Colon polyps are common among adults ≥50 years and people with colon polyps are recommended to undergo regular follow-up colonoscopy (surveillance) in hopes of preventing subsequent colorectal cancer (CRC). Older adults, particularly those who are age ≥70 years, most of whom have a history of only small colon polyps, may benefit little from repeated colonoscopies because of the increased risks of colonoscopy due to age and co-morbidities and potentially limited life expectancy due to other competing medical problems - CRC may never be a problem for them. Older adults may also be hesitant to get repeated colonoscopy because of the risk of complications (e.g., bleeding, perforation, etc.) and inconvenience. More surveillance options are needed to help address the concerns and challenges with repeated colonoscopies in older adults with a history of low-risk polyps. FIT is a noninvasive, stool-based test that is recommended and widely used in the US and globally for CRC screening in average-risk adults 45 to 75 years of age. In addition, FIT is already standard of care as a surveillance option for patients with a history of low-risk adenomas in Canada and has been shown to be equivalent to colonoscopy for screening of certain high-risk populations (e.g., those with a family history of CRC). However, FIT's role for surveillance among older adults who have a history of low-risk adenomas has not been studied in the US nor among older adults who may benefit from this noninvasive surveillance approach. The COOP Trial will fill this evidence gap and shed light on patient-, clinician-, and system-factors relevant to FIT for surveillance that together could potentially transform surveillance guidelines in the US and beyond The purpose of this study is to compare annual at-home stool-based testing, with a fecal immunochemical test (FIT), to colonoscopy in adults age 65-82 who have a history of colorectal polyps. The goal of the study is to compare how well FIT works compared to colonoscopy in looking for and finding colorectal cancer in older adults who have a history of colorectal polyps, as well as to understand people's experiences with using it compared to colonoscopy.
Eligibility criteria
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
Study design
Enrollment target: 8946 participants
Allocation: randomized
Masking: none
Age groups: older_adult
Timeline
Starts: 2023-06-14
Estimated completion: 2035-12-31
Last updated: 2025-09-23
Interventions
Diagnostic Test: FITDiagnostic Test: Colonoscopy
Primary outcomes
  • 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)
Sponsor
Dartmouth-Hitchcock Medical Center · other
With: Patient-Centered Outcomes Research Institute
Contacts & investigators
ContactKelsey M Veilleux, MD · contact · coopstudy@hitchcock.org · (603) 650-6226
InvestigatorAudrey H Calderwood, MD, MS · principal_investigator, Dartmouth-Hitchcock Medical Center
InvestigatorTheodore R Levin, MD · principal_investigator, Kaiser Permante Northern California
All locations (19)
University of Alabama BirminghamActive Not Recruiting
Birmingham, Alabama, United States
University of ArizonaRecruiting
Tucson, Arizona, United States
Kaiser Permanente Northern CaliforniaRecruiting
Walnut Creek, California, United States
University of ColoradoRecruiting
Aurora, Colorado, United States
MedStar HealthRecruiting
Washington D.C., District of Columbia, United States
James A. Haley Veterans HospitalRecruiting
Tampa, Florida, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Rockford Gastroenterology AssociatesRecruiting
Rockford, Illinois, United States
Richard L. Roudebush VA Medical CenterRecruiting
Indianapolis, Indiana, United States
University of Michigan HealthRecruiting
Ann Arbor, Michigan, United States
Dartmouth HealthRecruiting
Lebanon, New Hampshire, United States
New York Harbor Health Care System - Dept of Veterans AffairsRecruiting
New York, New York, United States
Kaiser Permanente NorthwestActive Not Recruiting
Portand, Oregon, United States
Oregon Health & Science University (Knight Cancer Institute)Recruiting
Portland, Oregon, United States
Intermountain HealthRecruiting
Sandy City, Utah, United States
University of Virginia HealthRecruiting
Charlottesville, Virginia, United States
University of British ColumbiaRecruiting
Vancouver, British Columbia, Canada
University of ManitobaRecruiting
Winnipeg, Manitoba, Canada
Colonoscopy vs Stool Testing for Older Adults With Colon Polyps · TrialPath