FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study
University of Chicago
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.
Description
Lynch syndrome (LS), the most common inherited cause of colorectal cancer (CRC) affecting about 1.2 million Americans. Colonoscopy starting early in adulthood and repeated yearly or biennially is the only recommended surveillance strategy which translates into about 25-50 lifetime colonoscopies. This intensive colonoscopy surveillance is not ideal because CRC risk varies widely by LS gene and age, colonoscopies are invasive, costly, and not readily accessible to all patients, and adherence is suboptimal. This clinical study will examine the performance of the fecal immunochemical test (FIT) i…
Eligibility
- Age range
- 20–80 years
- Sex
- All
- Healthy volunteers
- No
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 en…
Interventions
- OtherFecal immunochemical test
Detects blood in stool
Locations (3)
- The University of Chicago Medical CenterChicago, Illinois
- University of MichiganAnn Arbor, Michigan
- Columbia UniversityNew York, New York