FITting Non-invasive Tests in Lynch Syndrome Surveillance

Launched by UNIVERSITY OF CHICAGO · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial, called "FITting Non-invasive Tests in Lynch Syndrome Surveillance," is looking to compare two different tests for monitoring patients with Lynch Syndrome, a genetic condition that increases the risk of colorectal cancer. The study will evaluate how well a simple stool test called the fecal immunochemical test (FIT) works compared to the more invasive colonoscopy, which is a procedure where a doctor looks inside the colon using a camera. The goal is to see if the stool test can be a reliable alternative for regular check-ups in these patients.

To be eligible for the trial, participants need to have a confirmed diagnosis of Lynch Syndrome and be between the ages of 20 and 75, depending on the specific genetic variant they carry. They must also have a colonoscopy scheduled as part of their regular care. Unfortunately, individuals who have had certain surgeries, are pregnant, or have other specific health issues will not be able to join the study. If you participate, you can expect to take both the stool test and undergo a colonoscopy, allowing researchers to compare the results from both methods. This trial aims to improve the way we monitor people with Lynch Syndrome and potentially make screening easier and less invasive.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
• • Aged 20 - 75 years
• • 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 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.
• • Individuals who are pregnant.
• • Individuals with inflammatory bowel disease or active malignancy.
• • Individuals not willing or able to sign informed consent.