Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-13 @ 1:41 PM
Study NCT ID:
NCT05848050
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2023-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D013129', 'term': 'Spinal Puncture'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'monocentric, prospective, interventional, exploratory study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'molecular alteration profile of liquid biopsies', 'timeFrame': '1 day', 'description': 'Compare the molecular alteration profile of liquid biopsies (blood and CSF) to that of brain metastases.\n\nWill be determined in brain metastases and according to feasibility in liquid biopsies (blood and CSF):\n\n* Molecular alterations including in particular mutations, amplifications, Copy number gene variants and fusion transcripts identified by high-throughput sequencing ;\n* The rate of variation either in gain or in loss of expression of the different messenger Ribonucleic Acids by analysis of the transcriptome ;\n* Epigenetic alterations by methylation of deoxyribonucleic acid clusters by methylome chips.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine in brain metastases and according to feasibility in liquid biopsies:\n\n* Molecular alterations including in particular mutations, amplifications, Copy number gene variants and fusion transcripts identified by high-throughput sequencing;\n* The rate of variation either in gain or in loss of expression of the different messenger Ribonucleic Acids by analysis of the transcriptome;\n* Epigenetic alterations by methylation of deoxyribonucleic acid clusters by methylome chips.', 'detailedDescription': 'This is a single-center, prospective, interventional, exploratory study aimed at comparing the molecular alteration profile of liquid biopsies (blood and lumbar puncture) to that of brain metastases.\n\nThe population eligible for the study will consist of any patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision.\n\nThe study consists of comparing, between brain metastases and liquid biopsies (blood and lumbar puncture), the profiles of genomic, post-genomic and epigenetic alterations as well as the mutational load. To do this, the study only requires a lumbar puncture and a blood test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 or over;\n* Patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision (contrast enhancement of at least 1 cm);\n* Patient able to understand the information related to the study and to read the information leaflet;\n* Patient having signed a written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patient with a medical contraindication to surgery and anesthesia;\n* Patient whose anatomical location of the cerebral metastasis contraindicates wide resection;\n* Patient with a contraindication to performing a lumbar puncture;\n* Pregnant, parturient or breastfeeding women;\n* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;\n* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;\n* Patient not benefiting from a social security scheme.'}, 'identificationModule': {'nctId': 'NCT05848050', 'acronym': 'METALIQ', 'briefTitle': 'Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases', 'orgStudyIdInfo': {'id': '2022-A02785-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'brain metastases from solid cancer', 'description': 'Excision of the cerebral metastasis', 'interventionNames': ['Procedure: biological samples (blood test and lumbar puncture)']}], 'interventions': [{'name': 'biological samples (blood test and lumbar puncture)', 'type': 'PROCEDURE', 'description': 'On the day of excision of the cerebral metastasis, additional biological samples (blood test and lumbar puncture) will be taken in the operating room.\n\nA biological sample of the tumor tissue (brain metastases of a solid cancer with contrast uptake of at least 1 cm accessible to surgical excision) will also be taken and preserved by freezing, in accordance with current practice and after obtaining their written agreement. .\n\nBiological samples (liquid biopsies and tumour) from patients who have explicitly expressed their consent will be kept after the end of the research as part of a biobank in order to be able to carry out any additional analyses.', 'armGroupLabels': ['brain metastases from solid cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Privé Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}