NCT06218433 Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
| NCT ID | NCT06218433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-04-10 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-04-10 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Jussi Nikkola, MD, PhD
PRINCIPAL INVESTIGATOR
Tampere University Hospital
Frequently Asked Questions
Who can join the NCT06218433 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06218433 currently recruiting?
Yes, NCT06218433 is actively recruiting participants. Contact the research team at jussi.nikkola@fimnet.fi for enrollment information.
Where is the NCT06218433 trial being conducted?
This trial is being conducted at Vancouver, Canada, Tampere, Finland.
Who is sponsoring the NCT06218433 clinical trial?
NCT06218433 is sponsored by Tampere University Hospital. The principal investigator is Jussi Nikkola, MD, PhD at Tampere University Hospital. The trial plans to enroll 200 participants.