RecruitingNCT06898996

FITting Non-invasive Tests in Lynch Syndrome Surveillance

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

Sponsor

University of Chicago

Enrollment

400 participants

Start Date

Jul 10, 2025

Study Type

OBSERVATIONAL

Conditions

Colorectal, Cancer

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.

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Inclusion Criteria5

Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
Aged 20 - 75 years (for those with pathogenic variants in MLH1, MSH2, and EPCAM)
Aged 30 - 75 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).
Willing to sign informed consent, collect stools samples and complete surveys

Exclusion Criteria7

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.