Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT05025969
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2021-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The genomic analyses will be performed on tumour samples collected in routine practice during brain tumour removal surgery (glioma or brain metastasis) and the clinico-biological data will be collected from the medical records.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NTRK Fusion', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Incidence of NTRK gene fusion identified by RNAseq in glioma and brain metastasis tumour samples.'}], 'secondaryOutcomes': [{'measure': 'NTRK Fusion identification in brain metastasis and primary tumor', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Incidence of NTRK gene fusion identified in matched pairs of brain metastasis and primary tumor;'}, {'measure': 'Progression-free survival in patients with NTRK gene fusion', 'timeFrame': 'Month 6', 'description': 'Progression-free survival in patients with NTRK gene fusion. Progression-free survival is defined as the time from the date of initial surgery to the date of diagnosis of progression. Progression will be defined according to the RANO criteria at 6 months'}, {'measure': 'Progression-free survival in patients with NTRK gene fusion', 'timeFrame': 'Month 12', 'description': 'Progression-free survival in patients with NTRK gene fusion. Progression-free survival is defined as the time from the date of initial surgery to the date of diagnosis of progression. Progression will be defined according to the RANO criteria at 12 months'}, {'measure': 'Overall survival in patients with NTRK gene fusion.', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Overall survival in patients with NTRK gene fusion. Overall survival is defined as the time from the date of initial surgery to the date of death (or the date of last news) of the patient.'}, {'measure': 'Specific radiological criterion (T1)', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Specific radiological criteria (T1) in patients with NTRK gene fusion in gliomas and brain metastases'}, {'measure': 'Specific radiological criterion (T2)', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Specific radiological criteria (T2) in patients with NTRK gene fusion in gliomas and brain metastases'}, {'measure': 'Specific radiological criterion (FLAIR)', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Specific radiological criteria (FLAIR) in patients with NTRK gene fusion in gliomas and brain metastases'}, {'measure': 'Specific radiological criterion (perfusion)', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Specific radiological criteria (perfusion) in patients with NTRK gene fusion in gliomas and brain metastases'}, {'measure': 'Incidence of other genomic alterations', 'timeFrame': 'through study completion, an average of 12 months', 'description': 'Incidence of other genomic alterations identified by RNAseq, associated with the incidence of NTRK gene fusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'This is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: NTRK gene fusion, in adult gliomas and brain metastases.', 'detailedDescription': 'Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated for glioma or brain metastasis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female subject;\n* Glioma or brain metastasis operated on in our institution, histologically confirmed (WHO classification 2016);\n* Subject with a frozen tumour sample \\< 5 years old;\n* Subject for whom all clinico-radiological data are available;\n* Subject affiliated to a health insurance scheme;\n* Subject who has been informed of the research and who has not indicated his opposition to the use of his medical data and who has signed a consent for the use of his tumour sample.\n\nExclusion Criteria:\n\n* Patient under legal protection, guardianship or deprived of liberty by judicial or administrative decision\n* Biological samples not available and/or in insufficient quantity for analysis'}, 'identificationModule': {'nctId': 'NCT05025969', 'acronym': 'NTRK Fusion', 'briefTitle': 'Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours', 'orgStudyIdInfo': {'id': 'COS-RGDS-2020-06-072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glioma', 'description': '(20 grade II gliomas, 20 grade III gliomas and 20 glioblastomas)', 'interventionNames': ['Other: Glioma data collection']}, {'label': 'Brain metastasis', 'description': 'The "brain metastasis" cohort consists of 80 patients, including 30 patients for whom the matched primary tumour is available', 'interventionNames': ['Other: Brain metastasis data collection']}], 'interventions': [{'name': 'Glioma data collection', 'type': 'OTHER', 'description': 'Glioma data collection', 'armGroupLabels': ['Glioma']}, {'name': 'Brain metastasis data collection', 'type': 'OTHER', 'description': 'Brain metastasis data collection', 'armGroupLabels': ['Brain metastasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Privé Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Philippe METELLUS, MD PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Privé Clairval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}