Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-28 @ 12:03 AM
Study NCT ID:
NCT04943094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-31
First Post:
2021-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive 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': 'D001749', 'term': 'Urinary Bladder 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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in urodynamic specifics (bladder compliance, detrusor overactivity, maximal cystometric capacity)', 'timeFrame': 'examined at time 0 and after six months', 'description': 'Obtained from the urodynamic test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-muscle Invasive Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The aim is to evaluate and compare treatment strategies for non-muscle invasive bladder cancer. Furthermore, the impact of intravesical instillations on bladder function will be examined by urodynamic examination both prior to and following instillation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with primary non-muscle invasive bladder cancer or who are diagnosed with their first or second recurrence.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-muscle invasive bladder tumour\n\nExclusion Criteria:\n\n* more than one previous bladder tumour recurrence\n* muscle invasive bladder cancer (at baseline or prior to inclusion)\n* utilization of urinary catheter\n* have had heart valve replacement performed\n* pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT04943094', 'acronym': 'URODYN', 'briefTitle': 'Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy', 'orgStudyIdInfo': {'id': 'URODYN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TURBT alone', 'description': 'Patients treated with TURBT without adjuvant instillation therapy', 'interventionNames': ['Other: Urodynamic examination']}, {'label': 'TURBT and mitomycin C', 'description': 'Patients treated with TURBT followed by six adjuvant instillations with mitomycin C', 'interventionNames': ['Other: Urodynamic examination']}, {'label': 'TURBT and bacillus Calmette-Guerin', 'description': 'Patients treated with TURBT followed by six adjuvant instillations with BCG', 'interventionNames': ['Other: Urodynamic examination']}], 'interventions': [{'name': 'Urodynamic examination', 'type': 'OTHER', 'description': 'A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.', 'armGroupLabels': ['TURBT alone', 'TURBT and bacillus Calmette-Guerin', 'TURBT and mitomycin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Jørgen B. Jensen, DMSc, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jørgen Bjerggaard Jensen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}