Colon Cancer Clinical Trial

Colonoscopy vs Stool Testing for Older Adults Colon Polyps

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 70-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

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Full Description

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 70-82 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.

View Eligibility Criteria

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 ADLs or IADLs, 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 with an existing, scheduled appointment for surveillance colonoscopy
Patients unable to provide written informed consent
Patients who lack a valid mailing address

Study is for people with:

Colon Cancer

Estimated Enrollment:

8946

Study ID:

NCT05612347

Recruitment Status:

Not yet recruiting

Sponsor:

Dartmouth-Hitchcock Medical Center

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There are 5 Locations for this study

See Locations Near You

University of Alabama Birmingham
Birmingham Alabama, 35233, United States More Info
Douglas Morgan, MD, MPH
Contact
Kaiser Permanente Northern California
Walnut Creek California, 94596, United States More Info
Jeffrey Lee, MD, MPH
Contact
University of Colorado
Aurora Colorado, 80045, United States More Info
Swati Patel, MD, MS
Contact
Dartmouth Health
Lebanon New Hampshire, 03756, United States More Info
Audrey Calderwood, MD, MS
Contact
Kaiser Permanente Northwest
Portland Oregon, 97232, United States More Info
Gloria Coronado, PhD
Contact

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

8946

Study ID:

NCT05612347

Recruitment Status:

Not yet recruiting

Sponsor:


Dartmouth-Hitchcock Medical Center

How clear is this clinincal trial information?

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