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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: t
View:

• Willing and able to provide informed consent

• Diagnosis of Lynch syndrome

• Age 50 - 75 years at study recruitment

Locations
Other Locations
Canada
Vancouver Prostate Centre
RECRUITING
Vancouver
Finland
Tampere University Hospital and Tampere University
RECRUITING
Tampere
Contact Information
Primary
Jussi Nikkola, MD, PhD
jussi.nikkola@fimnet.fi
03311611
Time Frame
Start Date: 2023-04-10
Estimated Completion Date: 2034-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Screening arm
Invitation to participate in urothelial cancer screening and questionnaires
Related Therapeutic Areas
Sponsors
Leads: Tampere University Hospital
Collaborators: Tampere University

This content was sourced from clinicaltrials.gov