Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 8:15 AM
Study NCT ID:
NCT06310759
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Characteristics of urothelial cancers that were not detected by the utDNA test', 'timeFrame': 'Immediately after pathological examination of surgical tissue', 'description': '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)'}, {'measure': 'Concordance between utDNA and urine cytology results', 'timeFrame': 'Immediately after completion of utDNA analysis and urine cytology', 'description': 'Concordance between utDNA and urine cytology results, with respect to positivity of the test'}], 'primaryOutcomes': [{'measure': 'Sensitivity and specificity of urine tumor DNA (utDNA) test for urothelial cancer detection', 'timeFrame': '1 year after diagnostic workup', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of cystoscopy for urothelial cancer detection', 'timeFrame': '1 year after diagnostic workup', 'description': 'Sensitivity and specificity of cystoscopy for urothelial cancer detection, using histologically confirmed cancer diagnoses within 1 year of the diagnostic workup as ground truth'}, {'measure': 'Sensitivity and specificity of urine cytology for urothelial cancer detection', 'timeFrame': '1 year after diagnostic workup', 'description': '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'}, {'measure': 'Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy', 'timeFrame': '2, 5, and 10 years after diagnostic utDNA testing', 'description': 'Time to diagnosis of urothelial cancer in patients with a positive utDNA test but negative cystoscopy'}, {'measure': 'Adverse event rate for cystoscopy', 'timeFrame': '4 weeks after cystoscopy', 'description': 'Adverse event rate for cystoscopy, based on CTCAE 5.0'}, {'measure': 'Technical success rate of utDNA test', 'timeFrame': 'Immediately after utDNA sample analysis', 'description': 'Fraction of all analyzed urine samples for which the analysis met the quality control criteria for a technically successful analysis'}, {'measure': 'Estimate of diagnostic cystoscopies avoided', 'timeFrame': '4 weeks after cystoscopy', 'description': '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)'}, {'measure': 'Specificity of high-stringency utDNA threshold', 'timeFrame': '1 year after diagnostic workup', 'description': 'Specificity of a high-stringency utDNA threshold (at least 2 known urothelial cancer driver mutations with allele fraction \\> 5%) for clinically detectable urothelial cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urothelial neoplasms', 'Bladder neoplasms', 'Upper tract urothelial neoplasms', 'Liquid biopsies', 'Urine tumor DNA'], 'conditions': ['Urothelial Carcinoma']}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for diagnostic cystoscopy to rule out urothelial cancer due to hematuria, imaging, or urine cytology findings.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Patient has been scheduled for cystoscopy to rule out urothelial cancer\n\nExclusion Criteria:\n\n* Prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)'}, 'identificationModule': {'nctId': 'NCT06310759', 'acronym': 'UROSCOUT-1', 'briefTitle': 'Prospective Validation Study of High Volume Urine DNA Testing in Individuals With Suspicion of Urothelial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'R21088B'}}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joel Cornfield', 'role': 'CONTACT'}], 'facility': 'Jesse Brown Department Of Veterans Affairs Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Peter Black', 'role': 'CONTACT'}, {'name': 'Peter Black', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vancouver Prostate Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Tuomas Jalanko', 'role': 'CONTACT'}, {'name': 'Riikka Järvinen', 'role': 'CONTACT'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Pori', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Marjo Seppänen', 'role': 'CONTACT'}], 'facility': 'Satasairaala Hospital', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'city': 'Seinäjoki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Henry Haapiainen', 'role': 'CONTACT'}], 'facility': 'Seinäjoki Central Hospital', 'geoPoint': {'lat': 62.79446, 'lon': 22.82822}}, {'city': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jussi Nikkola', 'role': 'CONTACT'}, {'name': 'Thea Veitonmäki', 'role': 'CONTACT'}, {'name': 'Jussi Nikkola', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matti Annala', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tampere University Hospital and Tampere University', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pertti Nurminen', 'role': 'CONTACT'}, {'name': 'Peter Boström', 'role': 'CONTACT'}], 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazutoshi Fujita', 'role': 'CONTACT'}], 'facility': 'Kindai University Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'centralContacts': [{'name': 'Jussi Nikkola, MD PhD', 'role': 'CONTACT', 'email': 'jussi.nikkola@fimnet.fi', 'phone': '03311611', 'phoneExt': '+358'}], 'overallOfficials': [{'name': 'Jussi Nikkola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}