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.
Willing and able to provide informed consent
Patient has been scheduled for cystoscopy to rule out urothelial cancer
Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)
Patients scheduled for diagnostic cystoscopy to rule out urothelial cancer due to hematuria, imaging, or urine cytology findings.
Cohort
Prospective
Not listed
Sensitivity 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
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
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 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
Adverse event rate for cystoscopy
Adverse event rate for cystoscopy, based on CTCAE 5.0
Characteristics of urothelial cancers that were not detected by the utDNA test
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)
Concordance between utDNA and urine cytology results
Concordance between utDNA and urine cytology results, with respect to positivity of the test
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Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
