Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

NCT05612347 | Recruiting DMC

• 2 other identifiers: STUDY02001984PLACER-2020C3-20955
• Study Type: interventional
• Target: 8,946
• Locations: 2 countries
• Sites: 19

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.

Conditions

Colorectal Polyp; Colorectal Neoplasms; Colorectal Adenoma; Colorectal Cancer; Digestive System Disease

Keywords

Colonoscopy; Fecal immunochemical test (FIT)

Outcome Measures

Primary Outcomes (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.

  Up to 11 years

Secondary Outcomes (6)

• 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.

  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)

  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)

  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)

  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

  Baseline and annually for up to 6 years

Study Arms (2)

FIT

ACTIVE COMPARATOR

FIT (annual)

Diagnostic Test: FIT

Colonoscopy

ACTIVE COMPARATOR

Surveillance colonoscopy (one time)

Diagnostic Test: Colonoscopy

Interventions

FIT DIAGNOSTIC_TEST

Annual FIT

FIT

Colonoscopy DIAGNOSTIC_TEST

One time surveillance colonoscopy

Colonoscopy

Eligibility Criteria

• Age: 65 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (19)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

ACTIVE NOT RECRUITING

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

Kaiser Permanente Northern California

Walnut Creek, California, 94596, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MedStar Health

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

RECRUITING

James A. Haley Veterans Hospital

Tampa, Florida, 33612-4745, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Rockford Gastroenterology Associates

Rockford, Illinois, 61107, United States

RECRUITING

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Michigan Health

Ann Arbor, Michigan, 48105, United States

RECRUITING

Dartmouth Health

Lebanon, New Hampshire, 03756, United States

RECRUITING

New York Harbor Health Care System - Dept of Veterans Affairs

New York, New York, 10010, United States

RECRUITING

Kaiser Permanente Northwest

Portand, Oregon, 97232, United States

ACTIVE NOT RECRUITING

Oregon Health & Science University (Knight Cancer Institute)

Portland, Oregon, 97239, United States

RECRUITING

Intermountain Health

Sandy City, Utah, 84094, United States

RECRUITING

University of Virginia Health

Charlottesville, Virginia, 22903, United States

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3EOW3, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 32044092 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25127679 BACKGROUND

• 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.

  PMID: 31563271 BACKGROUND

• 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.

  PMID: 19528563 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Digestive System Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Audrey H Calderwood, MD, MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Theodore R Levin, MD

  Kaiser Permante Northern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey M Veilleux, MD

CONTACT

(603) 650-6226; coopstudy@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 10, 2022
• Study Start: June 14, 2023
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: September 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (17); CA (2)