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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Jesse Brown Department Of Veterans Affairs Medical Center
Chicago, Illinois, United States
NOT_YET_RECRUITINGVancouver Prostate Centre
Vancouver, British Columbia, Canada
RECRUITINGHelsinki University Hospital
Helsinki, Finland
RECRUITINGSatasairaala Hospital
Pori, Finland
RECRUITINGSeinäjoki Central Hospital
Seinäjoki, Finland
RECRUITINGTampere University Hospital and Tampere University
Tampere, Finland
RECRUITINGTurku University Hospital
Turku, Finland
RECRUITINGKindai University Hospital
Osaka, Japan
RECRUITINGSensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection
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
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 of urine cytology for urothelial cancer detection
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: 1 year after diagnostic workup
Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy
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
Adverse event rate for cystoscopy, based on CTCAE 5.0
Time frame: 4 weeks after cystoscopy
Technical success rate of utDNA test
Fraction of all analyzed urine samples for which the analysis met the quality control criteria for a technically successful analysis
Time frame: Immediately after utDNA sample analysis
Estimate of diagnostic cystoscopies avoided
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: 4 weeks after cystoscopy
Specificity of high-stringency utDNA threshold
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: 1 year after diagnostic workup
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