Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-03-13 @ 9:32 PM
Study NCT ID:
NCT02300532
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2014-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001254', 'term': 'Astrocytoma'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 561}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2014-11-21', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events/Serious Adverse Events', 'timeFrame': 'Up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': 'Up to 1 year', 'description': 'Survival rate of subjects measured up to 1 year after implantation of Gliadel'}]}, 'conditionsModule': {'keywords': ['Malignant Glioma', 'Glioblastoma Multiforme'], 'conditions': ['Malignant Glioma']}, 'descriptionModule': {'briefSummary': 'Post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of Gliadel with malignant glioma in the actual medical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diagnosed malignant glioma treated by surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* All-patient of Gliadel implantation\n\nExclusion criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02300532', 'briefTitle': 'Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Post-Marketing Surveillance of Gliadel 7.7mg Implant (All-case Observational Study)', 'orgStudyIdInfo': {'id': 'GLI01S'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}