NCT05612347 Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
| NCT ID | NCT05612347 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dartmouth-Hitchcock Medical Center |
| Condition | Colorectal Polyp |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,434 participants |
| Start Date | 2023-06-14 |
| Primary Completion | 2030-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,434 participants in total. It began in 2023-06-14 with a primary completion date of 2030-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Audrey H Calderwood, MD, MS
PRINCIPAL INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Frequently Asked Questions
Who can join the NCT05612347 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 82 Years, studying Colorectal Polyp. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05612347 currently recruiting?
Yes, NCT05612347 is actively recruiting participants. Contact the research team at coopstudy@hitchcock.org for enrollment information.
Where is the NCT05612347 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, San Diego, United States, Walnut Creek, United States and 11 additional locations.
Who is sponsoring the NCT05612347 clinical trial?
NCT05612347 is sponsored by Dartmouth-Hitchcock Medical Center. The principal investigator is Audrey H Calderwood, MD, MS at Dartmouth-Hitchcock Medical Center. The trial plans to enroll 6,434 participants.