Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03876093
Status:
WITHDRAWN
Last Update Posted:
2021-04-27
First Post:
2019-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epilepsy-related Brain Tumors Register
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The PI decided.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of epileptic seizures', 'timeFrame': 'Day 1', 'description': 'number of epileptic seizures at the time of neurology consultation or hospitalization'}], 'secondaryOutcomes': [{'measure': 'number of epileptic seizures', 'timeFrame': 'until 10 years', 'description': 'number of epileptic seizures at every visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Epilepsy is defined by a cerebral disorder characterized by a lasting predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological and social consequences of this affection. The definition of epilepsy requires the occurrence of at least one epileptic seizure. 1% of the population suffers from epilepsy. The most common causes are genetic and vascular, 10% of epileptic syndromes are caused by a tumor.\n\nThe incidence of brain tumors in people with epilepsy is approximately 4%. Among patients with brain tumor (s), the frequency of epilepsy is 30% or more depending on type of tumeur. 30-50% of brain tumors are revealed by an epileptic seizure and 10 to 30% of patients with brain tumor (s) will develop seizures during their evolution.\n\nThe main objective is to evaluate the frequency of epileptic seizures according to the type of brain tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized following an epileptic seizure or seen in consultation in the neurology department of the GHPSJ, diagnosed with primary or secondary brain tumor from January 2013 to December 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient whose age ≥ 18 years\n* Patient hospitalized or seen in consultation in the Department of Neurology within the Hospital Group Paris Saint-Joseph\n* Diagnosis of primary or secondary brain tumor, radiologically and / or histologically\n* Epilepsy revealing or occurring in a patient developing a brain tumor\n* Francophone patient\n\nExclusion Criteria:\n\n* Pre-existing and known epilepsy before the diagnosis of brain tumors\n* Epilepsy occurring within 2 weeks postoperatively\n* Anteriority of taking antiepileptic treatment\n* Patient under tutorship or curatorship\n* Patient deprived of liberty\n* Patient with comprehension disorders making it impossible to understand the protocol\n* Patient or relative opposing the use of his data'}, 'identificationModule': {'nctId': 'NCT03876093', 'briefTitle': 'Epilepsy-related Brain Tumors Register', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Epilepsy-related Brain Tumors Register', 'orgStudyIdInfo': {'id': 'Epilepsy-related brain tumors'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roubeau Vincent, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}