Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-28 @ 11:02 PM
Study NCT ID:
NCT03676868
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2018-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002538', 'term': 'Intracranial Arteriovenous Malformations'}, {'id': 'D012421', 'term': 'Rupture'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020785', 'term': 'Central Nervous System Vascular Malformations'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-11-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic', 'timeFrame': '6 months', 'description': 'associaton between dosage of endothelial marker in blood samples and correlation with clinical outcome'}, {'measure': 'Associaton between dosage of platelet and the arteriovenous malformation pronostic', 'timeFrame': '6 months', 'description': 'Dosage of platelet in blood samples and correlation with clinical outcome'}, {'measure': 'Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic', 'timeFrame': '6 months', 'description': 'Dosage of neutrophilic in blood samples and correlation with clinical outcome'}, {'measure': 'Associaton between neo-angiogenesis activation markers and the arteriovenous malformation pronostic', 'timeFrame': '6 months', 'description': 'Dosage neo-angiogenesis activation markers in blood samples and correlation with clinical outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Arteriovenous Malformations', 'Ruptured or Unruptured Cerebral Arteriovenous Malformations']}, 'descriptionModule': {'briefSummary': 'The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.\n\nThe cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.\n\nThe hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with a cerebral arterioveinus malformation for which an intervention (endovascular treatment or surgery) or only clinical monitoring is planned', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient over 18 years old\n* Patient with a cerebral AVM for which an intervention (endovascular treatment or surgery) or only clinical monitoring\n* Express consent to participate in the study\n\nAnd\n\n* children\n* Free informed and express consent of both holders of the minor patient's parental authority, or, by way of derogation and only if the other holder of parental authority cannot give his or her consent within a time limit compatible with the methodological requirements specific to the conduct of the research with regard to its purposes, of one of the two holders of parental authority\n\nExclusion Criteria:\n\n* Patient benefiting from a legal protection measure\n* Pregnant or breast feeding woman"}, 'identificationModule': {'nctId': 'NCT03676868', 'acronym': 'BioMAV', 'briefTitle': 'Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Biology of Cerebral Arteriovenous Malformations : Study of the Link Between Blood Biomarkers and the Haemorrhagic Prognosis of Cerebral Arteriovenous Malformations', 'orgStudyIdInfo': {'id': 'JDS_2018_6'}}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dr Jean-Philippe DESILLES', 'role': 'CONTACT', 'email': 'jpdesilles@for.paris'}], 'facility': 'Fondation Ophtalmologique Rotschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Amélie Yavchitz', 'role': 'CONTACT', 'email': 'ayavchitz@for.paris', 'phone': '01 48 63 64 54', 'phoneExt': '+33'}, {'name': 'Jean Philippe DESILLES', 'role': 'CONTACT', 'email': 'jp.desilles@for.paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}