NCT05612347 · Dartmouth-Hitchcock Medical Center
Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
(COOP)
What this study is about
This is a multi-site comparative effectiveness randomly assigned 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
FIT
Annual FIT
DIAGNOSTIC_TEST
Colonoscopy
One time surveillance colonoscopy
Primary outcome measures
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.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Tucson, Arizona
- San Diego, California
- Walnut Creek, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Tampa, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Ann Arbor, Michigan
- Detroit, Michigan
- St Louis, Missouri
And 8 more locations — see the full list below.
Collaborators
Patient-Centered Outcomes Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2026 · Source of record for eligibility and locations