Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
NCT ID: NCT05612347
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
8946 participants
INTERVENTIONAL
2023-06-14
2035-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM)
NCT01239082
A Clinic-wide Intervention (Primary Care-GI Connect) for Improving Rates of Colonoscopy After Abnormal Fecal Immunochemical Test Result in Patients at Federally Qualified Health Centers
NCT06568016
Screening for Stomach Diseases and Colorectal Neoplasms With the Fecal Testing
NCT01741363
Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening
NCT02738359
Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps
NCT06376565
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FIT
FIT (annual)
FIT
Annual FIT
Colonoscopy
Surveillance colonoscopy (one time)
Colonoscopy
One time surveillance colonoscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FIT
Annual FIT
Colonoscopy
One time surveillance colonoscopy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
65 Years
82 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dartmouth-Hitchcock Medical Center
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Audrey H. Calderwood
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Audrey H Calderwood, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Theodore R Levin, MD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permante Northern California
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Kaiser Permanente Northern California
Walnut Creek, California, United States
University of Colorado
Aurora, Colorado, United States
MedStar Health
Washington D.C., District of Columbia, United States
James A. Haley Veterans Hospital
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Rockford Gastroenterology Associates
Rockford, Illinois, United States
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, United States
University of Michigan Health
Ann Arbor, Michigan, United States
Dartmouth Health
Lebanon, New Hampshire, United States
New York Harbor Health Care System - Dept of Veterans Affairs
New York, New York, United States
Kaiser Permanente Northwest
Portand, Oregon, United States
Oregon Health & Science University (Knight Cancer Institute)
Portland, Oregon, United States
Intermountain Health
Sandy City, Utah, United States
University of Virginia Health
Charlottesville, Virginia, United States
University of British Columbia
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sunil Patel, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
Dubé C, McCurdy BR, Bronstein T, et al. ColonCancerCheck Recommendations for Post-Polypectomy Surveillance, 2019. Available at: https://www.cancercareontario.ca/en/content/coloncancercheck-recommendations-post-polypectomy-surveillance
Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
Kothari ST, Huang RJ, Shaukat A, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Khashab MA, Jamil LH, Jue TL, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Thosani N, Yang J, DeWitt JM, Wani S; ASGE Standards of Practice Committee Chair. ASGE review of adverse events in colonoscopy. Gastrointest Endosc. 2019 Dec;90(6):863-876.e33. doi: 10.1016/j.gie.2019.07.033. Epub 2019 Sep 25.
Warren JL, Klabunde CN, Mariotto AB, Meekins A, Topor M, Brown ML, Ransohoff DF. Adverse events after outpatient colonoscopy in the Medicare population. Ann Intern Med. 2009 Jun 16;150(12):849-57, W152. doi: 10.7326/0003-4819-150-12-200906160-00008.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PLACER-2020C3-20955
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY02001984
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.