Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT02300506
Status:
COMPLETED
Last Update Posted:
2018-11-05
First Post:
2014-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
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': 507}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-02', 'studyFirstSubmitDate': '2014-11-21', 'studyFirstSubmitQcDate': '2014-11-24', 'lastUpdatePostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': 'Up to 3 years', 'description': 'Survival rate of subjects measured up to 3 year after implantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malignant Glioma', 'Glioblastoma multiforme'], 'conditions': ['Malignant Glioma']}, 'referencesModule': {'references': [{'pmid': '35118382', 'type': 'DERIVED', 'citation': 'Iuchi T, Inoue A, Hirose Y, Morioka M, Horiguchi K, Natsume A, Arakawa Y, Iwasaki K, Fujiki M, Kumabe T, Sakata Y. Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan. Neurooncol Adv. 2022 Jan 12;4(1):vdab189. doi: 10.1093/noajnl/vdab189. eCollection 2022 Jan-Dec.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).'}, '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* Malignant Glioma, patients enrolled in study GLI01S.\n\nExclusion criteria:\n\n* Corresponding to contraindication of Gliadel.\n* Not applicable to indications of Gliadel.'}, 'identificationModule': {'nctId': 'NCT02300506', 'briefTitle': 'Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma', 'orgStudyIdInfo': {'id': 'GLI02T'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg, and enrolled in study GLI01S.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}