Prospective Validation Study of High Volume Urine DNA Testing in Individuals with Suspicion of Urothelial Cancer

Recruiting

• Conditions: Urothelial Carcinoma

• Registration Number: NCT06310759
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-08
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection	1 year after diagnostic workup	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

Secondary Outcome Measures

Name	Time	Method
Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy	2, 5, and 10 years after diagnostic utDNA testing	Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy
Specificity of high-stringency utDNA threshold	1 year after diagnostic workup	Specificity of a high-stringency utDNA threshold (at least 2 known urothelial cancer driver mutations with allele fraction \> 5%) for clinically detectable urothelial cancer
Sensitivity and specificity of cystoscopy for urothelial cancer detection	1 year after diagnostic workup	Sensitivity and specificity of cystoscopy for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth
Adverse event rate for cystoscopy	4 weeks after cystoscopy	Adverse event rate for cystoscopy, based on CTCAE 5.0
Sensitivity and specificity of urine cytology for urothelial cancer detection	1 year after diagnostic workup	Sensitivity and specificity or urine cytology for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth
Technical success rate of utDNA test	Immediately after utDNA sample analysis	Fraction of all analyzed urine samples for which the analysis met the quality control criteria for a technically successful analysis
Estimate of diagnostic cystoscopies avoided	4 weeks after cystoscopy	Estimated fraction of diagnostic cystoscopies that could have been avoided by pre-screening patients with a utDNA test (calculated as the fraction of all diagnostic utDNA samples that were negative and for which subsequent cystoscopy did not lead to clinical interventions)

Trial Locations

Locations (8)

Jesse Brown Department Of Veterans Affairs Medical Center; 🇺🇸 Chicago, Illinois, United States

Vancouver Prostate Centre; 🇨🇦 Vancouver, British Columbia, Canada

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Satasairaala Hospital; 🇫🇮 Pori, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Tampere University Hospital and Tampere University; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Kindai University Hospital; 🇯🇵 Osaka, Japan