Screening for bladder cancer in people with Lynch syndrome using urine tests
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
NA · Tampere University Hospital · NCT06218433
This study is testing a new urine test to see if it can better find bladder cancer early in people with Lynch syndrome compared to the usual methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Tampere University Hospital (other) |
| Locations | 2 sites (Vancouver and 1 other locations) |
| Trial ID | NCT06218433 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on individuals diagnosed with Lynch syndrome, a hereditary condition that increases the risk of various cancers, particularly urothelial carcinoma. The study aims to utilize a urine tumor DNA panel to detect asymptomatic urothelial cancers in this high-risk population, comparing its effectiveness against traditional urine cytology methods. By identifying cancers early, the trial seeks to improve outcomes for patients with Lynch syndrome, who have a significant lifetime risk of developing urothelial cancer. Participants will be recruited from specific locations, including Tampere University Hospital and the Vancouver Prostate Centre.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 to 75 years who have been diagnosed with Lynch syndrome.
Not a fit: Patients who currently have urothelial carcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of urothelial cancers in Lynch syndrome patients, potentially improving survival rates.
How similar studies have performed: While the approach of using urine tumor DNA for cancer screening is promising, it is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vancouver and 1 other locations
- Vancouver Prostate Centre — Vancouver, Canada (RECRUITING)
- Tampere University Hospital and Tampere University — Tampere, Finland (RECRUITING)
Study contacts
- Principal investigator: Jussi Nikkola, MD, PhD — Tampere University Hospital
- Study coordinator: Jussi Nikkola, MD, PhD
- Email: jussi.nikkola@fimnet.fi
- Phone: 03311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urothelial Carcinoma, Lynch Syndrome, Lynch syndrome, Hereditary cancer syndrome, Screening, Urothelial neoplasms, Bladder neoplasms, Upper tract urothelial neoplasms