Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT02647112
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2015-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1050}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2015-12-16', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)', 'timeFrame': 'Day 1', 'description': 'the proportion of positives that are correctly identified as such by the gold standard'}, {'measure': 'Specificity (the proportion of negatives that are correctly identified as such by the gold standard)', 'timeFrame': 'Day 1', 'description': 'the proportion of negatives that are correctly identified as such by the gold standard'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bladder cancer', 'Urine', 'Methylation'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.', 'detailedDescription': 'Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma\n* Has all urothelial cell carcinoma tumor resected within the past 12 months\n* Has a plan for cystoscopic surveillance\n\nExclusion Criteria:\n\n* Planning to undergo radical cystectomy or chemotherapy-radiation for UCC'}, 'identificationModule': {'nctId': 'NCT02647112', 'briefTitle': 'Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nucleix Ltd.'}, 'officialTitle': 'Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study', 'orgStudyIdInfo': {'id': 'UC-EpiCheck-EU-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bladder EpiCheck', 'description': 'Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology', 'interventionNames': ['Other: Bladder EpiCheck']}, {'type': 'NO_INTERVENTION', 'label': 'Practice of medicine', 'description': 'Practice of medicine including cystoscopy and cytology'}], 'interventions': [{'name': 'Bladder EpiCheck', 'type': 'OTHER', 'description': 'Urine test for the monitoring of bladder cancer recurrence', 'armGroupLabels': ['Bladder EpiCheck']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tübingen', 'country': 'Germany', 'facility': 'Tubingen University Medical Center', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'AMC Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Hengelo', 'country': 'Netherlands', 'facility': 'ZGT Medical Center', 'geoPoint': {'lat': 52.26583, 'lon': 6.79306}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall D'Hebron Medical Center", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Shmulik Adler', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nucleix Ltd.'}, {'name': 'Fred Witjes, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nucleix Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}