Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
Recruiting · NCT06218433 · Interventional (participants receive a specific treatment) · Lead sponsor: Tampere University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Willing and able to provide informed consent
- Diagnosis of Lynch syndrome
- Age 50 - 75 years at study recruitment
Exclusion criteria
- Concurrent urothelial carcinoma
Where it is running
2 locations listed.
- Tampere University Hospital and Tampere University - Tampere, Finland
- Vancouver Prostate Centre - Vancouver, Canada