Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urothelial Carcinoma. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Finland, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Prospective Multicenter Validation Study Investigating the Possibility of Replacing Cystoscopies With High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer (UROSCOUT-1)
Overview
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 measures
- Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection [Time frame: 1 year after diagnostic workup]
Secondary outcome measures (7)
- Sensitivity and specificity of cystoscopy for urothelial cancer detection [Time frame: 1 year after diagnostic workup]
- Sensitivity and specificity of urine cytology for urothelial cancer detection [Time frame: 1 year after diagnostic workup]
- Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy [Time frame: 2, 5, and 10 years after diagnostic utDNA testing]
- Adverse event rate for cystoscopy [Time frame: 4 weeks after cystoscopy]
- Technical success rate of utDNA test [Time frame: Immediately after utDNA sample analysis]
- Estimate of diagnostic cystoscopies avoided [Time frame: 4 weeks after cystoscopy]
- Specificity of high-stringency utDNA threshold [Time frame: 1 year after diagnostic workup]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Finland · 5 centers
- Helsinki University Hospital — Helsinki
- Satasairaala Hospital — Pori
- Seinäjoki Central Hospital — Seinäjoki
- Tampere University Hospital and Tampere University — Tampere
- Turku University Hospital — Turku
United States · 1 center
- Jesse Brown Department Of Veterans Affairs Medical Center — Chicago
Canada · 1 center
- Vancouver Prostate Centre — Vancouver
Japan · 1 center
- Kindai University Hospital — Osaka
Identifiers
NCT: NCT06310759 · R21088B