Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 3:23 AM
Study NCT ID:
NCT02077504
Status:
TERMINATED
Last Update Posted:
2018-05-09
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glial Tumors Electromagnetic Signature Study by MagnetoEncephaloGraphy (MEG) "CONDUCTOME"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015225', 'term': 'Magnetoencephalography'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D060306', 'term': 'Magnetometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2013-09-18', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction', 'timeFrame': '1 week before exeresis'}, {'measure': 'anatomopathologic and clinical data in tumor grade prediction', 'timeFrame': '1 week after exeresis'}], 'secondaryOutcomes': [{'measure': 'Measurement of molecules involved in glial cells neuralisation expression in tumor samples', 'timeFrame': 'Up to 1 month after surgery'}, {'measure': 'Tumoral growth modelisation from patient MEG and MRI data', 'timeFrame': 'Up to 1 month after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebral Primitive Tumor With Chirurgical Indication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response.', 'detailedDescription': 'A better tumor grade definition would provide an optimized surgical care, prognosis and therapeutical response evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more or equal than 18 years old\n* patient affiliated to social security or similarly regime\n* informed consent form signed\n* supra-tentorial primitive cerebral tumor\n\nExclusion Criteria:\n\n* Pregnant women and lactating mothers\n* Ward of court or under guardianship\n* Adult unable to express their consent\n* Person deprived of freedom by judicial or administrative decision\n* Person hospitalized without their consent\n* Person under legal protection\n* Magnetic Resonance Imaging (MRI) contraindication (implanted material non MRI-compatible, ferro-magnetic foreign body, claustrophobia)\n* Patients needed emergency medical care for other pathology\n* severely altered general health (Performance Status 3 or 4)'}, 'identificationModule': {'nctId': 'NCT02077504', 'acronym': 'CONDUCTOME', 'briefTitle': 'Glial Tumors Electromagnetic Signature Study by MagnetoEncephaloGraphy (MEG) "CONDUCTOME"', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Magnetoencephalographic Study of Glial Tumors Electromagnetic Signature', 'orgStudyIdInfo': {'id': 'CONDUCTOME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CONDUCTOME', 'description': 'MEG and MRI', 'interventionNames': ['Other: MEG and MRI']}], 'interventions': [{'name': 'MEG and MRI', 'type': 'OTHER', 'description': 'CONDUCTOME', 'armGroupLabels': ['CONDUCTOME']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CLINATEC', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'François BERGER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Grenoble Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}