NCT06310759 Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
| NCT ID | NCT06310759 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Urothelial Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2024-01-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Jussi Nikkola
PRINCIPAL INVESTIGATOR
Tampere University Hospital
Frequently Asked Questions
Who can join the NCT06310759 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06310759 currently recruiting?
Yes, NCT06310759 is actively recruiting participants. Contact the research team at jussi.nikkola@fimnet.fi for enrollment information.
Where is the NCT06310759 trial being conducted?
This trial is being conducted at Chicago, United States, Vancouver, Canada, Helsinki, Finland, Pori, Finland and 4 additional locations.
Who is sponsoring the NCT06310759 clinical trial?
NCT06310759 is sponsored by Tampere University Hospital. The principal investigator is Jussi Nikkola at Tampere University Hospital. The trial plans to enroll 3,000 participants.