nctId: NCT06310759 id: R21088B briefTitle: Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer acronym: UROSCOUT-1 overallStatus: RECRUITING date: 2024-01-08 date: 2026-12-31 date: 2029-12-31 date: 2024-03-15 date: 2024-03-15 name: Tampere University Hospital class: OTHER name: Tampere University briefSummary: 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. conditions: Urothelial Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection measure: Sensitivity and specificity of cystoscopy for urothelial cancer detection measure: Sensitivity and specificity of urine cytology for urothelial cancer detection measure: Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy measure: Adverse event rate for cystoscopy measure: Technical success rate of utDNA test measure: Estimate of diagnostic cystoscopies avoided measure: Specificity of high-stringency utDNA threshold measure: Characteristics of urothelial cancers that were not detected by the utDNA test measure: Concordance between utDNA and urine cytology results sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vancouver Prostate Centre status: NOT_YET_RECRUITING city: Vancouver state: British Columbia country: Canada name: Peter Black role: CONTACT name: Peter Black role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 facility: Helsinki University Hospital status: NOT_YET_RECRUITING city: Helsinki country: Finland name: Riikka Järvinen role: CONTACT name: Tuomas Jalanko role: CONTACT lat: 60.16952 lon: 24.93545 facility: Tampere University Hospital and Tampere University status: RECRUITING city: Tampere country: Finland name: Jussi Nikkola role: CONTACT name: Thea Veitonmäki role: CONTACT name: Jussi Nikkola role: PRINCIPAL_INVESTIGATOR name: Matti Annala role: PRINCIPAL_INVESTIGATOR lat: 61.49911 lon: 23.78712 facility: Turku University Hospital status: NOT_YET_RECRUITING city: Turku country: Finland name: Peter Boström role: CONTACT name: Otto Ettala role: CONTACT lat: 60.45148 lon: 22.26869 hasResults: False