Actively Recruiting
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
Led by Tampere University Hospital · Updated on 2025-11-18
200
Participants Needed
2
Research Sites
611 weeks
Total Duration
On this page
Sponsors
T
Tampere University Hospital
Lead Sponsor
T
Tampere University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Diagnosis of Lynch syndrome
- Age 50 - 75 years at study recruitment
You will not qualify if you...
- Concurrent urothelial carcinoma
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Vancouver Prostate Centre
Vancouver, Canada
Actively Recruiting
2
Tampere University Hospital and Tampere University
Tampere, Finland
Actively Recruiting
Research Team
J
Jussi Nikkola, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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