Home stool blood test (FIT) versus colonoscopy for people with Lynch syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls people with genetically confirmed Lynch syndrome who have an upcoming guideline-recommended surveillance colonoscopy. Participants collect a fecal immunochemical test (FIT) sample before their routine colonoscopy, and researchers compare FIT results to colonoscopy findings to measure sensitivity, specificity, and predictive values. The study also uses participant surveys to document attitudes toward and acceptability of non-invasive testing. Multiple academic centers (University of Chicago, Columbia University, University of Michigan) participate to capture a diverse clinical population.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Sonia Kupfer, MD — University of Chicago
• Study coordinator: Sonia Kupfer, MD
• Email: skupfer@bsd.uchicago.edu
• Phone: (773) 834-1438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.