Validation of urine DNA testing for diagnosing urothelial cancer
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)
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 |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 8 sites (Chicago, Illinois and 7 other locations) |
| Trial ID | NCT06310759 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals scheduled for cystoscopy to rule out urothelial cancer who are willing to provide informed consent.
Not a fit: Patients with a prior diagnosis of urothelial cancer will not benefit from this study.
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 performed: Other studies exploring liquid biopsies and urine DNA testing have shown promise, indicating potential success for this novel approach.
Eligibility criteria
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 this trial is running
Chicago, Illinois and 7 other locations
- Jesse Brown Department Of Veterans Affairs Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
- 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)
- Kindai University Hospital — Osaka, Japan (Recruiting)
Study contacts
- Principal investigator: Jussi Nikkola — 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.