PREDI-LYNCH – Redefining cancer surveillance for Lynch Syndrome

PREDI-LYNCH (Protocol UC-GIG-2522) is a multicenter, randomized study evaluating whether a non-invasive, multimodal surveillance strategy can safely improve cancer detection in people with Lynch syndrome (LS), a hereditary condition that raises the risk of colorectal, endometrial, and urothelial cancers.

The trial will enroll 2,000 adults (ages 35–80) with a confirmed pathogenic variant in MLH1, MSH2, MSH6, or EPCAM, randomizing them 1:1 to either standard-of-care surveillance (colonoscopy every 18 months) or an experimental strategy combining extended-interval colonoscopy (at baseline and 36 months) with annual liquid biopsy testing — blood (ctDNA), urine, vaginal swab, and stool samples.

The goal is to determine whether this less invasive, genomically informed approach is non-inferior to standard colonoscopy-based screening for detecting cancer, while easing the physical, emotional, and economic burden of frequent invasive procedures. If successful, PREDI-LYNCH could shift Lynch syndrome surveillance toward a more precise, patient-centered, and scalable model of early cancer detection.

• Duration: 10 years
• Role: Coordinating PI, WP3 leader