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Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
NCT06310759 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (8)
Other
- Helsinki University Hospital — Helsinki
- Satasairaala Hospital — Pori
- Seinäjoki Central Hospital — Seinäjoki
- Tampere University Hospital and Tampere University — Tampere
- Turku University Hospital — Turku
- Kindai University Hospital — Osaka
Illinois
- Jesse Brown Department Of Veterans Affairs Medical Center — Chicago
British Columbia
- Vancouver Prostate Centre — Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2024-01-08 |
| Est. Completion | 2029-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06310759
The ClinicalTrials.gov registry entry for NCT06310759 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tampere University Hospital, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06310759 reports 8 study locations spanning 3 distinct geographic areas — top geographies include Other, Illinois, British Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06310759 about?
NCT06310759 is a clinical study titled "Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer". 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...
What is the current status of trial NCT06310759?
This trial is currently recruiting. The enrollment target is 3,000 participants. The study started on 2024-01-08. Estimated completion is 2029-12-31.
What conditions does trial NCT06310759 study?
This clinical trial studies the following conditions: Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT06310759?
This trial is sponsored by Tampere University Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06310759 being conducted?
This trial has 8 study locations across Illinois, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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