Recruiting

FIT vs. Colonoscopy

Sponsor:

University of Chicago

Code:

NCT06898996

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Fecal immunochemical test

Study Details

Brief summary:

The purpose of this clinical study is to evaluate the accuracy of the fecal immunochemical test (FIT) in comparison to colonoscopy in patients with Lynch Syndrome (LS) who are undergoing colonoscopy surveillance.

Conditions

Colorectal Cancer

Study ID

NCT06898996

Start date

Jul 10, 2025

Status verified date

Apr, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
  • Aged 20 - 80 years (for those with pathogenic variants in MLH1, MSH2, and EPCAM)
  • Aged 30 - 80 years (for those with pathogenic variants in PMS2 or MSH6).
  • Have an upcoming standard of care (SOC) colonoscopy appointment in line with standard LS surveillance guidelines (NCCN).
  • Patients with previous colon surgery who still have 20cm or more of colon remaining
  • Patients who are diagnosed with advanced neoplasia (e.g., advanced adenomas or cancers) and have NOT had endoscopic or surgical resection
  • Willing to sign informed consent, collect stools samples and complete surveys

Exclusion Criteria:

  • Individuals who have not proceeded with genetic testing and therefore are not known to have LS, despite family history and/or criteria for testing.
  • Individuals who have previously undergone a subtotal or total colectomy.
  • Newly diagnosed Lynch Syndrome patients < 20 years old with a pathogenic variant in MLH1, MSH2 or EPCAM, MSH6 or PMS2.
  • Newly diagnosed Lynch Syndrome patients < 30 years old with a pathogenic variant in MSH6 or PMS2.
  • Individuals who are pregnant.
  • Individuals with inflammatory bowel disease or active malignancy.
  • Individuals not willing or able to sign informed consent.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-invasive surveillance test

Easily accessible, affordable and acceptable tests can be used to triage Lynch syndrome patients to colonoscopy

Interventions

Fecal immunochemical test

Detects blood in stool

Primary outcome measure

  • Quantitative Measure of specificity [ Time Frame: baseline -12 months ]

Central Contacts and Locations

Central contacts

Sonia Kupfer, MD

(773) 834-1438skupfer@bsd.uchicago.edu

Kristi Kearney, RN

773-834-7414kkearney@bsd.uchicago.edu

Locations

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60639

Contacts

Sonia Kupfer, MD

773-834-1438skupfer@bsd.uchicago.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Elena Stoffel, MD

734-647-7558estoffel@med.umich.edu

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Fay Kastrinos, MD

212-305-1021fk18@cumc.columbia.edu

More Information

Sponsor

University of Chicago

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Lynch Syndrome
  • Colorectal Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-16.