Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)

Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Urothelial cancers (comprising bladder and upper tract urothelial tumors) are the third most common cancer after colorectal and endometrial cancers in individuals with LS. Up to one in four LS individuals will develop urothelial cancer during their lifetime, with the risk varying based on the defective MMR gene. In this clinical trial, we will employ urine tumor DNA (utDNA) to identify asymptomatic urothelial cancers in Lynch syndrome patients, and to investigate the potential benefits of urine tumor DNA based screening in this high-risk population.

NCT Number	NCT06218433
Lead Sponsor	Tampere University Hospital Collaborators: Tampere University
Conditions	Urothelial Carcinoma, Lynch Syndrome
Enrollment	200 participants
Start Date	2023-04-10
Primary Completion	2026-12-30 (estimated)
Study Completion	2034-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-18