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FITting Non-invasive Tests in Lynch Syndrome Surveillance

RecruitingObservational study

FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study

Who can join

Ages 20 to 80 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: University of Chicago · Participants: 400 · Started: Jul 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06898996

Locations in the U.S.

IllinoisThe University of Chicago Medical Center, Chicago
MichiganUniversity of Michigan, Ann Arbor
New YorkColumbia University, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.