Recruiting

FIT vs. Colonoscopy

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT05612347

Conditions

Colorectal Polyp

Colorectal Neoplasms

Colorectal Adenoma

Colorectal Cancer

Digestive System Disease

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

FIT

Colonoscopy

Study Details

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

Study ID

NCT05612347

Start date

Jun 14, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

May 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8946 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: FIT

FIT (annual)

active comparator: Colonoscopy

Surveillance colonoscopy (one time)

Interventions

FIT

Annual FIT

Colonoscopy

One time surveillance colonoscopy

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 ]

Central Contacts and Locations

Central contacts

Barbie Patel, MPH

857-4987233coopstudy@hitchcock.org

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Joshua Melson, MD

5206266119Cats-med@arizona.edu

Jennifer Moreno Department of Veterans Affairs Medical Cneter

Recruiting

San Diego, California, United States, 92161

Kaiser Permanente Northern California

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Jeffrey Lee, MD, MPH

cooptrial@kp.org

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Swati Patel, MD, MS

GI-CancerPreventionProgram@cuanschutz.edu

MedStar Health

Recruiting

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

Contacts

Theresa Moriarty

2028773657Theresa.M.Moriarty@medstart.net

Principal Investigator:

Jennifer Tran, MD

James A. Haley Veterans Hospital

Recruiting

Tampa, Florida, United States, 33612-4745

Contacts

Brijesh Patel, MD

(813) 619-5131Kamryn.woods@va.gov

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Zack Jacobs

3124729597IGIresearch@northwestern.edu

Principal Investigator:

Rajesh Keswani, MD

Richard L. Roudebush VA Medical Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Thomas Imperiale, MD

317-988-4859VHAINDVACOOPINDY@va.gov

University of Michigan Health

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Nabrah Lone

7346473635nabrahl@med.umich.edu

Principal Investigator:

Stacy Menees, MD

Henry Ford

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Dr. Suraj Suresh, MD

313-932-5502SSuresh1@hfhs.org

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Dr. Cassandra Fritz, MD

(314) 374-8335cfritz@wustl.edu

Dartmouth Health

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Audrey Calderwood, MD, MS

(603) 650-0220coopstudy@hitchcock.org

New York Harbor Health Care System - Dept of Veterans Affairs

Recruiting

New York, New York, United States, 10010

Contacts

Aasma Shaukat, MD

Aasma.Shaukat@nyulangone.org

Wake Forest University Health Sciences

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Dr. Lee Sigmon, MD

704-355-2000Lee.Sigmon@advocatehealth.org

Oregon Health & Science University (Knight Cancer Institute)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Seth Crockett, MD, MPH

(503)494-2278gastrohepresearch@ohsu.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Andrew Gawron, MD

801-581-7802andrew.gawron@hsc.utah.edu

Intermountain Health

Recruiting

Sandy City, Utah, United States, 84094

Contacts

Dr. Christine Hachem, MD, FACG

8015072112Christine.Hachem@imail.org

University of Virginia Health

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Cynthia Yoshida, MD

434-243-2124CoopStudy@virginia.edu

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 5A1

Contacts

Dr. Robert Hilsden, MD

403-592-5042rhilsden@ucalgary.ca

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Dr. Jennifer Telford, MD

6046886332jtelford29@gmail.com

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3EOW3

Contacts

Harminder Singh, MD

2047893369mycolonoscopy@umanitoba.ca

London Health Sciences Centre Research Institute

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Dr. Michael Sey, MD

519 685 8500michael.sey@lhsc.on.ca

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Aug 13, 2026

Last verified

May, 2026

Keywords

  • Colonoscopy
  • Fecal immunochemical test (FIT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-08-13.