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RECRUITINGOBSERVATIONAL

FITting Non-invasive Tests in Lynch Syndrome Surveillance

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form, collect stools samples and complete surveys Who Should NOT Join This Trial: - 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 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.

Treatments Being Tested

OTHER

Fecal immunochemical test

Detects blood in stool

Locations (3)

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