Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT04162704
Status:
UNKNOWN
Last Update Posted:
2021-08-11
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EpiCheck and Short-term Intensive Chemoresection in NMIBC
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urin samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EpiCheck result', 'timeFrame': 'One to two months after short-term, intensive chemoresection', 'description': 'Number of patients with accordance between EpiCheck score and clinical findings at the time of evaluation cystoscopy'}], 'secondaryOutcomes': [{'measure': 'EpiCheck result 2', 'timeFrame': 'One to two months after short-term, intensive chemoresection', 'description': 'Number of patients with discrepancy between EpiCheck score and clinical findings at the time of cystoscopy'}, {'measure': 'EpiCheck result 3', 'timeFrame': 'One to two months after short-term, intensive chemoresection', 'description': 'Trend of the EpiCheck test over time (increase/decrease/stable score) and its correlation to complete/incomplete tumour response'}, {'measure': 'Urine cytology', 'timeFrame': 'One to two months after short-term, intensive chemoresection', 'description': 'Sensitivity, specificity, negative and positive predictive value for urine cytology'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this explorative study is to evaluate whether EpiCheck can be used as a predictor of tumour response to short-term, intensive chemoresection with Mitomycin.', 'detailedDescription': 'The study will be conducted as an exploratory, prospective observational study. Participants consists of patients referred to short-term, intensive chemoresection due to recurrent NMIBC. The treatment adhere to the regimen described in the NICSA trial with the ClinicalTrials.gov identifier NCT03348969. Treatment consists of short-term, intensive chemoresection with Mitomycin; 40 mg is administered intravesically three times a week for two weeks. To evaluate tumour response, an early cystoscopy is performed in the outpatient clinic one to two months after treatment completion. No visible tumour and residual tumour with benign histology is considered complete response. Residual tumour tissue with neoplastic histology is considered incomplete response and will be treated with TURBT or tumour fulguration. Subsequently patients continue a standardized follow-up program as Danish guidelines prescribe which is initiated after four months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a known history of Ta HG with recurrent disease and who are referred to short-term, intensive chemoresection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a known history of Ta HG with recurrent disease\n* Patients referred to short-term, intensive chemoresection\n* Patients older than 18 years\n\nExclusion Criteria:\n\n* Known allergy or intolerance to Mitomycin\n* Incontinence or small bladder capacity (\\< 100 mL)\n* Previous pelvic radiation therapy'}, 'identificationModule': {'nctId': 'NCT04162704', 'briefTitle': 'EpiCheck and Short-term Intensive Chemoresection in NMIBC', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'EpiCheck and Short-term Intensive Chemoresection in NMIBC', 'orgStudyIdInfo': {'id': '1-10-72-207-19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EpiCheck', 'type': 'DEVICE', 'description': 'If the EpiCheck test is positive at the time of inclusion, the test is repeated prior to the fourth and sixth instillation with Mitomycin as well as prior to the subsequent two cystoscopies. If the EpiCheck test is negative at the time of inclusion, no further tests will be performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Maria S Lindgren, MD', 'role': 'CONTACT', 'email': 'maalin@rm.dk', 'phone': '30915431', 'phoneExt': '0045'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Maria S Lindgren, MD', 'role': 'CONTACT', 'email': 'maalin@rm.dk', 'phone': '30915431', 'phoneExt': '0045'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Skydt Lindgren', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}