Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT06218433
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sensitivity and specificity of urine cytology', 'timeFrame': 'At 1 year of follow-up', 'description': 'Sensitivity and specificity of urine cytology for detecting urothelial cancer, using histologically verified cancers detected within 1 year of cytology as ground truth'}, {'measure': 'Association of utDNA fraction with time to diagnosis of urothelial cancer', 'timeFrame': 'At 2, 5 and 10 years of follow-up', 'description': 'Association of utDNA fraction (quantified based on mutation allele fractions in urine DNA) with time to diagnosis of urothelial cancer'}, {'measure': 'Prevalence of somatic second hit in MMR genes', 'timeFrame': 'At 1, 2, 5 and 10 years of follow-up', 'description': 'Prevalence of somatic second hit and additional somatic hits in mismatch repair genes (MSH2, MSH6, MLH1, PMS2) in Lynch syndrome patients diagnosed with urothelial cancer'}, {'measure': 'Cost of utDNA screening', 'timeFrame': 'At 1, 2, 5 and 10 years of follow-up', 'description': 'Analysis of the cost of utDNA screening, including cost per urothelial cancer found'}], 'primaryOutcomes': [{'measure': 'Sensitivity and specificity of positive utDNA for urothelial cancer within one year of follow-up', 'timeFrame': 'At 1 years of follow-up', 'description': 'Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 1 year of the utDNA test as ground truth'}], 'secondaryOutcomes': [{'measure': 'Specificity of positive utDNA for urothelial cancer at the time of testing', 'timeFrame': 'After all patients with positive utDNA have been evaluated with cystoscopy and/or imaging', 'description': 'Specificity of positive utDNA test for urothelial cancer, using histologically verified cancers detected in the cystoscopy and/or imaging performed due to positive utDNA test as the ground truth'}, {'measure': 'Sensitivity and specificity of positive utDNA for urothelial cancer within multiple years of follow-up', 'timeFrame': 'At 2, 5, and 10 years of follow-up', 'description': 'Sensitivity and specificity of positive utDNA for urothelial cancer, using histologically verified cancers detected within 2, 5, and 10 years of the utDNA test as ground truth'}, {'measure': 'Overall survival', 'timeFrame': 'At 5 and 10 years of follow-up', 'description': 'Overall survival in utDNA positive and negative patients'}, {'measure': 'Urothelial cancer specific survival', 'timeFrame': 'At 3, 5 and 10 years of follow-up', 'description': 'Urothelial cancer specific survival survival in utDNA positive and negative patients'}, {'measure': 'Time to metastatic urothelial cancer', 'timeFrame': 'At 5 and 10 years of follow-up', 'description': 'Time to metastatic urothelial cancer in utDNA positive and negative patients'}, {'measure': 'Time to diagnosis of muscle invasive or high grade urothelial cancer', 'timeFrame': 'At 2, 5 and 10 years of follow-up', 'description': 'Time to diagnosis of muscle invasive or high grade urothelial cancer in utDNA positive and negative patients'}, {'measure': 'Time to diagnosis of urothelial cancer', 'timeFrame': 'At 2, 5 and 10 years of follow-up', 'description': 'Time to diagnosis of urothelial cancer in utDNA positive and negative patients'}, {'measure': 'TNM pathological stage of urothelial cancers', 'timeFrame': 'At 2, 5 and 10 years of follow-up', 'description': 'TNM pathological stage (American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC)) of urothelial cancers found in utDNA positive and negative patients'}, {'measure': 'Size of urothelial tumors', 'timeFrame': 'At 2, 5 and 10 years of follow-up', 'description': 'Maximum diameter of urothelial tumors found in utDNA positive and negative patients'}, {'measure': 'Urothelial cancer grade', 'timeFrame': 'At 2, 5 and 10 years of follow-up', 'description': 'The World Health Organization (WHO) 2004/2016 grading of urothelial cancers found in utDNA positive and negative patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lynch syndrome', 'Hereditary cancer syndrome', 'Screening', 'Urothelial neoplasms', 'Bladder neoplasms', 'Upper tract urothelial neoplasms', 'Urogenital diseases', 'Liquid biopsies', 'Urine tumor DNA'], 'conditions': ['Urothelial Carcinoma', 'Lynch Syndrome']}, 'descriptionModule': {'briefSummary': 'Lynch syndrome (LS) is an inherited cancer predisposition syndrome caused by pathogenic germline variants in DNA mismatch repair (MMR) genes. New cancer screening and diagnostic tools are urgently needed to identify LS-related cancers early enough for curative treatment. Urothelial cancers (comprising bladder and upper tract urothelial tumors) are the third most common cancer after colorectal and endometrial cancers in individuals with LS. Up to one in four LS individuals will develop urothelial cancer during their lifetime, with the risk varying based on the defective MMR gene. In this clinical trial, we will employ urine tumor DNA (utDNA) to identify asymptomatic urothelial cancers in Lynch syndrome patients, and to investigate the potential benefits of urine tumor DNA based screening in this high-risk population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Diagnosis of Lynch syndrome\n* Age 50 - 75 years at study recruitment\n\nExclusion Criteria:\n\n* Concurrent urothelial carcinoma'}, 'identificationModule': {'nctId': 'NCT06218433', 'briefTitle': 'Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)', 'orgStudyIdInfo': {'id': 'R22125'}, 'secondaryIdInfos': [{'id': 'R22125', 'type': 'OTHER', 'domain': 'Tampere University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening arm', 'description': 'Invitation to participate in urothelial cancer screening and questionnaires', 'interventionNames': ['Diagnostic Test: Urothelial cancer screening using urine tumor DNA test', 'Diagnostic Test: Urothelial cancer screening using urine cytology (comparator)']}], 'interventions': [{'name': 'Urothelial cancer screening using urine tumor DNA test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urine sample DNA is analyzed using a targeted sequencing panel encompassing the coding regions of 21 genes that are recurrently mutated in urothelial cancer', 'armGroupLabels': ['Screening arm']}, {'name': 'Urothelial cancer screening using urine cytology (comparator)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urine cytology sample', 'armGroupLabels': ['Screening arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', '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': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Jussi Nikkola', 'role': 'CONTACT'}, {'name': 'Jussi Nikkola', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matti Annala', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jukka-Pekka Mecklin', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Toni Seppälä', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tampere University Hospital and Tampere University', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'centralContacts': [{'name': 'Jussi Nikkola, MD, PhD', 'role': 'CONTACT', 'email': 'jussi.nikkola@fimnet.fi', 'phone': '03311611', 'phoneExt': '+358'}], 'overallOfficials': [{'name': 'Jussi Nikkola, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}