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NCT06310759 · ClinicalTrials.gov registry record
Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
A clinical trial of Urothelial Carcinoma, sponsored by Tampere University Hospital.
- Recruiting
- Registry status
- 3,000
- Enrollment target
- 8
- Study locations
NCT06310759: Recruiting study of Urothelial Carcinoma, sponsored by Tampere University Hospital.
NCT06310759 is a study of Urothelial Carcinoma that is actively recruiting participants, run by Tampere University Hospital. The registered enrollment target is 3,000 participants, above the 204-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (1371% higher). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06310759, a study of Urothelial Carcinoma, is actively recruiting participants, sponsored by Tampere University Hospital.
- RECRUITING
- Registry status
- 3,000 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
Sensitivity and specificity of utDNA test for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth
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 |
What NCT06310759 shows while recruiting
NCT06310759 is an observational study that tracks outcomes without assigning an intervention. Its 3,000 participants enrollment target places it among the larger protocols in the corpus, above the 204-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (1371% higher).
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 0 interventions.
NCT06310759 lists 8 locations in 3 states (Other, Illinois, British Columbia).
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.
Who is sponsoring clinical trial NCT06310759?
This trial is sponsored by Tampere University Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06310759's enrollment target sits among peer trials
3,000 1st of 85 higher than 85 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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