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