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Colorectal PolypCOOPNCT05612347

Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

A study testing FIT and Colonoscopy in people with Colorectal Polyp and Colorectal Neoplasms, run by Dartmouth-Hitchcock Medical Center at 24 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 to 82 years
What is being tested?
FIT and Colonoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,434 participants
Where
24 sitesin 2 countries
Study dates
14 Jun 2023to 31 Dec 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 82 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Barbie Patel, MPH contact

857-4987233

coopstudy@hitchcock.org

24 sites in 2 countries

United States20 sites, 18 recruiting

  • University of Michigan Health

    Ann Arbor, Michigan, 48105

    Nabrah Lone, 7346473635, nabrahl@med.umich.edu

    Stacy Menees, MD

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Swati Patel, MD, MS, GI-CancerPreventionProgram@cuanschutz.edu

    Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

    Active, not recruiting

  • Wake Forest University Health Sciences

    Charlotte, North Carolina, 28204

    Dr. Lee Sigmon, MD, 704-355-2000, Lee.Sigmon@advocatehealth.org

    Recruiting

  • University of Virginia Health

    Charlottesville, Virginia, 22903

    Cynthia Yoshida, MD, 434-243-2124, CoopStudy@virginia.edu

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Zack Jacobs, 3124729597, IGIresearch@northwestern.edu

    Rajesh Keswani, MD

    Recruiting

  • Henry Ford

    Detroit, Michigan, 48202

    Dr. Suraj Suresh, MD, 313-932-5502, SSuresh1@hfhs.org

    Recruiting

  • Richard L. Roudebush VA Medical Center

    Indianapolis, Indiana, 46202

    Thomas Imperiale, MD, 317-988-4859, VHAINDVACOOPINDY@va.gov

    Recruiting

  • Dartmouth Health

    Lebanon, New Hampshire, 03756

    Audrey Calderwood, MD, MS, (603) 650-0220, coopstudy@hitchcock.org

    Recruiting

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

    New York, New York, 10010

    Aasma Shaukat, MD, Aasma.Shaukat@nyulangone.org

    Recruiting

  • Kaiser Permanente Northwest

    Portand, Oregon, 97232

    Terminated

  • Oregon Health & Science University (Knight Cancer Institute)

    Portland, Oregon, 97239

    Seth Crockett, MD, MPH, (503)494-2278, gastrohepresearch@ohsu.edu

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Andrew Gawron, MD, 801-581-7802, andrew.gawron@hsc.utah.edu

    Lynette Holman

    Recruiting

  • Jennifer Moreno Department of Veterans Affairs Medical Cneter

    San Diego, California, 92161

    Dr. Samir Gupta

    Recruiting

  • Intermountain Health

    Sandy City, Utah, 84094

    Dr. Christine Hachem, MD, FACG, 8015072112, Christine.Hachem@imail.org

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Dr. Cassandra Fritz, MD, (314) 374-8335, cfritz@wustl.edu

    Recruiting

  • James A. Haley Veterans Hospital

    Tampa, Florida, 33612-4745

    Brijesh Patel, MD, (813) 619-5131, Kamryn.woods@va.gov

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85719

    Joshua Melson, MD, 5206266119, Cats-med@arizona.edu

    Recruiting

  • Kaiser Permanente Northern California

    Walnut Creek, California, 94596

    Jeffrey Lee, MD, MPH, cooptrial@kp.org

    Recruiting

  • MedStar Health

    Washington D.C., District of Columbia, 20010

    Theresa Moriarty, 2028773657, Theresa.M.Moriarty@medstart.net

    Jennifer Tran, MD

    Recruiting

Other trials in United States

Canada4 sites, 4 recruiting

  • University of Calgary

    Calgary, Alberta, T2N 5A1

    Dr. Robert Hilsden, MD, 403-592-5042, rhilsden@ucalgary.ca

    Recruiting

  • London Health Sciences Centre Research Institute

    London, Ontario, N6A 5W9

    Dr. Michael Sey, MD, 519 685 8500, michael.sey@lhsc.on.ca

    Recruiting

  • University of British Columbia

    Vancouver, British Columbia, V6Z 1Y6

    Dr. Jennifer Telford, MD, 6046886332, jtelford29@gmail.com

    Recruiting

  • University of Manitoba

    Winnipeg, Manitoba, R3EOW3

    Harminder Singh, MD, 2047893369, mycolonoscopy@umanitoba.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
FIT, Colonoscopy
Keywords
Colonoscopy, Fecal immunochemical test (FIT)
Medical subject headings
Colorectal Neoplasms, Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FITDiagnostic test

    Annual FIT

  • ColonoscopyDiagnostic test

    One time surveillance colonoscopy

Study groups in NCT05612347
Study groupRoleWhat they receive
FITActive comparatorFIT (annual)
Receives: Diagnostic Test: FIT
ColonoscopyActive comparatorSurveillance colonoscopy (one time)
Receives: Diagnostic Test: Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: Up to 11 years

Secondary outcomes (6)

  1. 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.

    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.

    Measured: Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years

  2. Change from baseline worry about colorectal Cancer assessed by the Cancer Worry Scale (CWS)

    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).

    Measured: Baseline and annually for up to 6 years

  3. Change from baseline Perceived colorectal cancer susceptibility using Absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010)

    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).

    Measured: Baseline, annually for up to 6 years

  4. Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ)

    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.

    Measured: Baseline and annually for up to 6 years

  5. Change from baseline perceived global health assessed by the Patient-Reported Outcomes Measurement Information System-Global 10

    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.

    Measured: Baseline and annually for up to 6 years

  6. Major and minor harms within 30 days of colonoscopy, as measured through chart review and telephone interview.

    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).

    Measured: 30-45 days post colonoscopy for up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2022
  2. Study start14 Jun 2023
  3. Primary completion31 May 2030 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,434 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05612347
Sponsor's protocol ID
STUDY02001984
Other IDs
PLACER-2020C3-20955
Acronym
COOP
Status last verified
May 2026
First submitted
4 Nov 2022
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • May S, Knight EM, Boyer N, Calderwood AH, Biddle KM, Marks AR, Badalov JM, Jensen CD, Levin TR, Robertson DJ, Cronholm PF, Kearney MD, Barg FK, Jones L, Edwards WD, O'Shea E, Geddes J, Schifferdecker KE. Mixed-Methods Development and Validation of PRO/PREM Items for Patients Undergoing Colon Polyp Surveillance. J Clin Gastroenterol. 2026 Apr 27. doi: 10.1097/MCG.0000000000002386. Online ahead of print.

    PubMed 42044221

  • Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.

    PubMed 32044092

  • Dubé C, McCurdy BR, Bronstein T, et al. ColonCancerCheck Recommendations for Post-Polypectomy Surveillance, 2019. Available at: https://www.cancercareontario.ca/en/content/coloncancercheck-recommendations-post-polypectomy-surveillance

  • Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.

    PubMed 25127679

  • Kothari ST, Huang RJ, Shaukat A, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Khashab MA, Jamil LH, Jue TL, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Thosani N, Yang J, DeWitt JM, Wani S; ASGE Standards of Practice Committee Chair. ASGE review of adverse events in colonoscopy. Gastrointest Endosc. 2019 Dec;90(6):863-876.e33. doi: 10.1016/j.gie.2019.07.033. Epub 2019 Sep 25.

    PubMed 31563271

  • Warren JL, Klabunde CN, Mariotto AB, Meekins A, Topor M, Brown ML, Ransohoff DF. Adverse events after outpatient colonoscopy in the Medicare population. Ann Intern Med. 2009 Jun 16;150(12):849-57, W152. doi: 10.7326/0003-4819-150-12-200906160-00008.

    PubMed 19528563

  • Robertson DJ, Dominitz JA, Beed A, Boardman K, Del Curto BJ, Guarino PD, Huang GD, Imperiale TF, LaCasse A, Larson M, Gupta S, Lieberman D, Planeta B, O'Leary TJ, Shaukat A, Sultan S, Kyriakides TC; CONFIRM Study Group. Race, ethnicity, and prior colorectal screening test use in CONFIRM colonoscopy vs fecal immunochemical testing trial participants. JNCI Cancer Spectr. 2026 Aug 26:pkag080. doi: 10.1093/jncics/pkag080. Online ahead of print.

    PubMed 42644818

Questions about this trial

What is this clinical trial studying?

A study testing FIT and Colonoscopy in people with Colorectal Polyp and Colorectal Neoplasms, run by Dartmouth-Hitchcock Medical Center at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Barbie Patel, MPH (857-4987233, coopstudy@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05612347, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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