NCT Number: NCT06310759
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Vancouver Prostate Centre, Vancouver, British Columbia, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks after cystoscopy
Adverse event rate for cystoscopy, based on CTCAE 5.0
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Immediately after pathological examination of surgical tissue
Characteristics of urothelial cancers that were not detected by the utDNA test (TNM pathological stage, World Health Organization (WHO) 2004/2016 grade, and tumor size)
Time frame: Immediately after completion of utDNA analysis and urine cytology
Concordance between utDNA and urine cytology results, with respect to positivity of the test
Contact information is provided by the study sponsor or research team.
Tampere University Hospital
Other
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)
Acronym: UROSCOUT-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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