Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02305056
Status:
TERMINATED
Last Update Posted:
2018-05-09
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2014-11-20', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass spectrometry measurement of C13 labelled proteins', 'timeFrame': 'during 30 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['High-grade Glioma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).', 'detailedDescription': 'The project aims to study protein turnover in glioblastoma using mass spectrometry after 13C-valine incorporation. This will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients With High-grade Glioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, '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* High-grade Glioma tumor suspicion\n* Resective surgery indication\n* Hematological assessment :\n\n * neutrophils \\> 1500/mm3\n * Platelet \\> 150 000\n * blood Creatinin normal\n * alkaline Phosphatases and transaminases no more than two times normal\n * Bilirubin \\< 1.5 times normal\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* Precedent complete macroscopic tumor resective surgery\n* No valid inclusion criteria\n* Intratumoral hemorrhage MRI detected\n* Treatment anticoagulant or antisludge treatments\n* Active Infections and non controled or medical affection or psychiatric intercurrent non treated\n* Evolutive cerebral oedema without corticoid response\n* Non controled Epilepsy without antiepileptics response\n* Karnofsky score \\< 40%\n* Weight \\> 100 kg\n* No possibility of resective surgery'}, 'identificationModule': {'nctId': 'NCT02305056', 'acronym': 'CARBONOMIC', 'briefTitle': 'Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'orgStudyIdInfo': {'id': 'CARBONOMIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C13 N15 Valine', 'description': 'Intervention C13 N15 Valine', 'interventionNames': ['Drug: C13 N15 Valine']}], 'interventions': [{'name': 'C13 N15 Valine', 'type': 'DRUG', 'otherNames': ['CARBONOMIC'], 'description': 'C13 N15 Valine administration', 'armGroupLabels': ['C13 N15 Valine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'CLINATEC', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'François BERGER, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Grenoble Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}