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Stool test vs. colonoscopy: which is better for older adults with polyps?

NCT ID NCT05612347

Diagnosis Sponsor: Dartmouth-Hitchcock Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study compares two ways to monitor older adults (ages 65-82) who have had colon polyps in the past: an annual stool test (FIT) or a colonoscopy every few years. About 9,000 participants will be randomly assigned to one of the two methods and followed for up to 11 years to see which approach detects advanced polyps or cancer better. The goal is to find the most effective and convenient screening option for this age group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that a simple annual stool test is as effective as colonoscopy for monitoring older adults with a history of polyps, potentially reducing the need for invasive procedures.
What could go wrong
This is a comparative effectiveness study, not a test of a new treatment. Results may show that stool testing misses some advanced polyps, and the findings may not apply to people with higher-risk conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 8,946 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 82 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colorectal adenoma colorectal neoplasm Digestive System Diseases digestive system disorder polyp of large intestine colorectal cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal adenoma Colorectal cancer Colorectal neoplasms Colorectal polyp Digestive system disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dartmouth Health

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

    Contact Email: •••••@•••••

  • Henry Ford

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Intermountain Health

    RECRUITING

    Sandy City, Utah, 84094, United States

  • James A. Haley Veterans Hospital

    RECRUITING

    Tampa, Florida, 33612-4745, United States

  • Jennifer Moreno Department of Veterans Affairs Medical Cneter

    RECRUITING

    San Diego, California, 92161, United States

  • Kaiser Permanente Northern California

    RECRUITING

    Walnut Creek, California, 94596, United States

    Contact Email: •••••@•••••

  • Kaiser Permanente Northwest

    ACTIVE_NOT_RECRUITING

    Portand, Oregon, 97232, United States

  • London Health Sciences Centre Research Institute

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • MedStar Health

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • New York Harbor Health Care System - Dept of Veterans Affairs

    RECRUITING

    New York, New York, 10010, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Oregon Health & Science University (Knight Cancer Institute)

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Richard L. Roudebush VA Medical Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • University of Alabama Birmingham

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 5A1, Canada

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3EOW3, Canada

  • University of Michigan Health

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Virginia Health

    RECRUITING

    Charlottesville, Virginia, 22903, United States

    Contact Email: •••••@•••••

  • Wake Forest University Health Sciences

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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