Colonoscopy vs Stool Testing for Older Adults With Colon Polyps (COOP)

May 1, 2026 updated by: Audrey H. Calderwood, Dartmouth-Hitchcock Medical Center

Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Interventional

Enrollment (Estimated)

8946

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5A1
        • Recruiting
        • University of Calgary
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • University of British Columbia
        • Contact:
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3EOW3
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre Research Institute
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona
        • Contact:
    • California
      • San Diego, California, United States, 92161
        • Recruiting
        • Jennifer Moreno Department of Veterans Affairs Medical Cneter
        • Contact:
          • Dr. Samir Gupta
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente Northern California
        • Contact:
    • Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Health
        • Principal Investigator:
          • Jennifer Tran, MD
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33612-4745
        • Recruiting
        • James A. Haley Veterans Hospital
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Principal Investigator:
          • Rajesh Keswani, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Richard L. Roudebush VA Medical Center
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • University of Michigan Health
        • Contact:
        • Principal Investigator:
          • Stacy Menees, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Health
        • Contact:
    • New York
      • New York, New York, United States, 10010
    • Oregon
      • Portand, Oregon, United States, 97232
        • Active, not recruiting
        • Kaiser Permanente Northwest
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University (Knight Cancer Institute)
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
        • Contact:
          • Lynette Holman
      • Sandy City, Utah, United States, 84094
        • Recruiting
        • Intermountain Health
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 82 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FIT
FIT (annual)
Diagnostic test: FIT
Annual FIT
Active Comparator: Colonoscopy
Surveillance colonoscopy (one time)
Diagnostic test: Colonoscopy
One time surveillance colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Satisfaction and Trust of colorectal screening testing assessed by Tiro et al (2005) Response Efficacy sub-scale from the general colorectal cancer screening survey.
Time Frame: Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years
The Response Efficacy sub-scale from the general colorectal cancer screening survey is a 2 item scale with five response options (1=strongly disagree, 2=mildly disagree, 3=don't know, 4=mildly agree, 5=strongly agree), such that each individual attains a score ranging from 2 to 10.
Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years
Change from baseline worry about colorectal Cancer assessed by the Cancer Worry Scale (CWS)
Time Frame: Baseline and annually for up to 6 years
The Cancer Worry Scale is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The scale consists of six questions with four response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).
Baseline and annually for up to 6 years
Change from baseline Perceived colorectal cancer susceptibility using Absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010)
Time Frame: Baseline, annually for up to 6 years
The absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010) is a three-question scale using four-point Likert format ranging from 1= strongly disagree to 4=strongly agree, such that each individual attains a score ranging from 3 (minimum susceptibility) to 12 (maximum susceptibility).
Baseline, annually for up to 6 years
Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ)
Time Frame: Baseline and annually for up to 6 years
The PCQ is a 22 question scale that has four response options (1=Not at all, 2=a little bit, 3=quite a bit, 4=a great deal) such that each individual attains a score ranging from 22 to 88.
Baseline and annually for up to 6 years
Change from baseline perceived global health assessed by the Patient-Reported Outcomes Measurement Information System-Global 10
Time Frame: Baseline and annually for up to 6 years
The Patient-Reported Outcomes Measurement Information System-10 is a 10-item scale that has five response options (5=excellent, 4=very good, 3=good, 2=fair, 1=poor) which assess overall QOL. Raw scores are transformed into T scores; higher T scores indicate greater endorsement of the construct being assessed. Scoring supports two summary scores: A Global Physical Health (GPH) score and a Global Mental Health (GMH) score.
Baseline and annually for up to 6 years
Major and minor harms within 30 days of colonoscopy, as measured through chart review and telephone interview.
Time Frame: 30-45 days post colonoscopy for up to 6 years
Major and minor harms within 30 days of colonoscopy will be collected through chart review and a telephone interview with participants 30-45 post study surveillance colonoscopy or study colonoscopy for positive FIT. The incidence of harms will be compared between the study groups (annual FIT and colonoscopy).
30-45 days post colonoscopy for up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Audrey H Calderwood, MD, MS, Dartmouth-Hitchcock Medical Center
  • Principal Investigator: Theodore R Levin, MD, Kaiser Permante Northern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2023

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02001984
  • PLACER-2020C3-20955 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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