Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
Recruiting now
Conditions studied: Urothelial Carcinoma
In brief
Urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. The most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). Millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. The UROSCOUT-1 trial is a prospective multicenter observational study that explores the potential of urine tumor DNA (utDNA) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. The goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. Sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. Random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.
Key facts
- Study ID
- NCT06310759
- Run by
- Tampere University Hospital
- People needed
- 3000
- Starts
- 2024-01-08
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2025-10-10
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willing and able to provide informed consent
- Patient has been scheduled for cystoscopy to rule out urothelial cancer
You may not qualify if…
- Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
Where it is running
- Kindai University Hospital — Osaka, Japan (enrolling)
- Vancouver Prostate Centre — Vancouver, British Columbia, Canada (enrolling)
- Helsinki University Hospital — Helsinki, Finland (enrolling)
- Satasairaala Hospital — Pori, Finland (enrolling)
- Seinäjoki Central Hospital — Seinäjoki, Finland (enrolling)
- Tampere University Hospital and Tampere University — Tampere, Finland (enrolling)
- Turku University Hospital — Turku, Finland (enrolling)
- Jesse Brown Department Of Veterans Affairs Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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