Validation of urine DNA testing for diagnosing urothelial cancer
Official title: Observational Prospective Multicenter Validation Study Investigating the Possibility of Replacing Cystoscopies With High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer (UROSCOUT-1)
Run by Tampere University Hospital · NCT06310759 · Data updated 2026-11-12
This study is testing whether a new urine test for cancer can help people suspected of having urothelial cancer avoid unnecessary procedures like cystoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 8 sites (Chicago, Illinois and 7 other locations) |
| Status | Recruiting |
| Started | January 8, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2029 |
| Registry record updated | October 10, 2025 |
| Trial ID | NCT06310759 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals scheduled for cystoscopy to rule out urothelial cancer who are willing to provide informed consent.
✕Probably not a fit
Patients with a prior diagnosis of urothelial cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate the effectiveness of high-volume urine tumor DNA (utDNA) testing as a non-invasive alternative to cystoscopy for individuals suspected of having urothelial cancer. By analyzing urine samples collected by mail, the study seeks to determine if utDNA testing can accurately rule out cancer in patients presenting with hematuria or other symptoms. The goal is to improve patient quality of life, reduce healthcare costs, and alleviate the burden on urology centers by decreasing the number of unnecessary cystoscopies performed. The analysis will be conducted in a blinded manner to ensure unbiased results.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for invasive cystoscopy procedures in patients suspected of urothelial cancer.
How similar studies have gone: Other studies exploring liquid biopsies and urine DNA testing have shown promise, indicating potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to provide informed consent * Patient has been scheduled for cystoscopy to rule out urothelial cancer Exclusion Criteria: * Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
Where it's running
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Vancouver Prostate Centre
Vancouver, British Columbia, Canada Recruiting -
Helsinki University Hospital
Helsinki, Finland Recruiting -
Satasairaala Hospital
Pori, Finland Recruiting -
Seinäjoki Central Hospital
Seinäjoki, Finland Recruiting -
Tampere University Hospital and Tampere University
Tampere, Finland Recruiting -
Turku University Hospital
Turku, Finland Recruiting
Show 2 more locations
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Kindai University Hospital
Osaka, Japan Recruiting -
Jesse Brown Department Of Veterans Affairs Medical Center
Chicago, Illinois, United States Not yet recruiting
Study contacts
- Principal investigator: Jussi Nikkola — Tampere University Hospital
- Study coordinator: Jussi Nikkola, MD PhD
- Email: jussi.nikkola@fimnet.fi
- Phone: 03311611
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.