Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-01-04 @ 8:50 AM
Study NCT ID:
NCT03005132
Status:
RECRUITING
Last Update Posted:
2016-12-29
First Post:
2016-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative Analysis of Human Glioblastoma Multiforme
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-23', 'studyFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5 years overall survival', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': '5 years disease-free survival', 'timeFrame': '5 years'}, {'measure': '10 years overall survival', 'timeFrame': '10 years'}, {'measure': '10 years disease-free survival', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GBM; Integrative Analysis; WES'], 'conditions': ['GBM']}, 'referencesModule': {'references': [{'pmid': '25651787', 'type': 'RESULT', 'citation': 'Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'Integrative analysis of GBM', 'detailedDescription': 'The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of GBM characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with GBM', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≤ 75 years with histologically proven GBM\n* No severe major organ dysfunction\n* World Health Organization (WHO) performance status of 0 or 1\n* No prior cancer chemotherapy\n\nExclusion Criteria:\n\n* Age ≥ 76\n* Severe major organ dysfunction\n* WHO performance status of \\>1\n* Prior cancer chemotherapy'}, 'identificationModule': {'nctId': 'NCT03005132', 'briefTitle': 'Integrative Analysis of Human Glioblastoma Multiforme', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Integrative Analysis of Human Glioblastoma Multiforme', 'orgStudyIdInfo': {'id': '2016-521-Rainy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal brain tissue', 'description': 'Normal brain tissue from GBM patients', 'interventionNames': ['Other: Normal brain tissue']}, {'label': 'GBM tissues', 'description': 'GBM tissues from GBM patients', 'interventionNames': ['Other: Normal brain tissue']}, {'label': 'Metastasis tissues', 'description': 'Metastasis tissues from GBM patients', 'interventionNames': ['Other: Normal brain tissue']}], 'interventions': [{'name': 'Normal brain tissue', 'type': 'OTHER', 'description': 'The investigators will extract total protein, DNA and RNA from the samples.', 'armGroupLabels': ['GBM tissues', 'Metastasis tissues', 'Normal brain tissue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Da Fu, PhD', 'role': 'CONTACT', 'email': 'fu800da900@126.com', 'phone': '00-86-21-66301604'}, {'name': 'Yushui Ma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Da Fu, PhD', 'role': 'CONTACT', 'email': 'fu800da900@126.com', 'phone': '00-86-21-66301604'}, {'name': 'Yushui Ma, BS', 'role': 'CONTACT', 'email': 'mayushui2015@126.com', 'phone': '00-86-21-66301604'}], 'overallOfficials': [{'name': 'Da Fu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}, {'name': 'Xiaoming Zhong, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Ganzhou City People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The investigators are willing to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Jilin University', 'class': 'OTHER'}, {'name': "Ganzhou City People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Da Fu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}