Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-29 @ 11:47 AM
Study NCT ID:
NCT03770468
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2018-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 599}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2018-11-18', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '1 year from last patient in'}, {'measure': 'Molecular profiling on FFPE samples', 'timeFrame': '1 year from last patient in', 'description': 'Profiling for cytosine-phosphate-guanosine (CpG) methylation patterns using the Illumina 850k bead array platform'}, {'measure': 'Molecular profiling on frozen samples', 'timeFrame': '1 year from last patient in', 'description': 'Samples will be subjected to whole exome sequencing'}, {'measure': 'Molecular profiling on frozen samples', 'timeFrame': '1 year from last patient in', 'description': 'Samples will be subjected to messenger ribonucleic acid (mRNA) sequencing'}, {'measure': 'Molecular profiling on frozen samples', 'timeFrame': '1 year from last patient in', 'description': 'Samples will be subjected to miRNA sequencing'}, {'measure': 'Molecular profiling on frozen samples', 'timeFrame': '1 year from last patient in', 'description': 'Samples will be subjected to microarray-based expression profiling'}, {'measure': 'Proteome profiling', 'timeFrame': '1 year from last patient in', 'description': 'Tumor cells will be microdissected from frozen sections and prepared for high-resolution mass spectrometry'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'This pro - and retrospective multicenter clinical epidemiological study studies the molecular genetic, host-derived and clinical determinants of glioblastoma patients with an overall survival of more than 5 years. The different research focusses are:\n\n* Identification of clinical parameters and patient characteristics / host-related factors in long-term survivors (Focus 1)\n* Identification of molecular tumor characteristics in long-term survivors (Focus 2)\n* Assessment of therapy-related parameters, including neuro-toxicity (Focus 3)\n* Immunological studies (Focus 4)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Glioblastoma patients with overall survival \\> 5 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years at diagnosis\n* Histopathological diagnosis of glioblastoma (reference histology available) and\n* Survival \\>5 years from diagnosis\n* Availability of tumor tissue from initial glioblastoma diagnosis (FFPE or fresh-frozen) to validate the diagnosis centrally.\n* Signed consent form (living patients) or ethics approval for anonymous data collection in case of retrospective analysis of deceased patients\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT03770468', 'briefTitle': 'Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma', 'orgStudyIdInfo': {'id': 'EORTC-1419-BTG'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood drawl', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115-5450', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute & Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitaetsklinikum Wien - AKH uniklinieken', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopitaux Universitaires Bordet-Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'CHU Lyon - Hopital neurologique Pierre Wertheimer', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopitaux de Marseille - Hôpital de La Timone (APHM)', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '6000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice - Hopital Pasteur', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopitaux de Paris - Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'Hopitaux de Paris - La Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '80480', 'city': 'Salouël', 'country': 'France', 'facility': "CHU d'Amiens - CHU Amiens - Hopital Sud", 'geoPoint': {'lat': 49.86988, 'lon': 2.2434}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitaetsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitaetsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitaetsklinikum - Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60528', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Ronellenfitsch Michael', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitaetsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'UniversitaetsKlinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Technische Universitaet Muenchen - Klinikum Rechts Der Isar', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '151 23', 'city': 'Athens', 'country': 'Greece', 'facility': 'Hygeia Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Di Padova - Istituto Oncologico Veneto IRCCS', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '1081HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC - locatie VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois - Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Univ. Spital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Michael Weller', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EORTC Study Coordinator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}