NCT06218433

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Urothelial Carcinoma
• Lynch Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urothelial cancer screening using urine tumor DNA test	Urine sample DNA is analyzed using a targeted sequencing panel encompassing the coding regions of 21 genes that are recurrently mutated in urothelial cancer
DIAGNOSTIC_TEST	Urothelial cancer screening using urine cytology (comparator)	Urine cytology sample

Timeline

• Start date: 2023-04-10
• Primary completion: 2026-12-30
• Completion: 2034-12-31
• First posted: 2024-01-23
• Last updated: 2025-11-18

Locations

2 sites across 2 countries: Canada, Finland