Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 3:30 PM
Study NCT ID:
NCT04109404
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-10', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of meningiomas caracteristics', 'timeFrame': '12 months', 'description': 'meningiomas caracteristics in patient treated with CYPROTERONE ACETATE or Progestin description'}], 'secondaryOutcomes': [{'measure': 'prescription status of progestogenic treatment', 'timeFrame': '12 months', 'description': 'indications, duration of treatment, name and type of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meningioma,', 'progestin,', 'cyproterone acetate'], 'conditions': ['Meningioma']}, 'referencesModule': {'references': [{'pmid': '26264069', 'type': 'BACKGROUND', 'citation': 'Bernat AL, Oyama K, Hamdi S, Mandonnet E, Vexiau D, Pocard M, George B, Froelich S. Growth stabilization and regression of meningiomas after discontinuation of cyproterone acetate: a case series of 12 patients. Acta Neurochir (Wien). 2015 Oct;157(10):1741-6. doi: 10.1007/s00701-015-2532-3. Epub 2015 Aug 12.'}, {'type': 'BACKGROUND', 'citation': 'S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.'}]}, 'descriptionModule': {'briefSummary': 'Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest', 'detailedDescription': 'Retrospective study in CHRU of brest, the investigators selected patient with history of méningioma and treated by CYPROTERONE ACETATE, CHLORMADINONE ACETATE and NOMEGESTROL ACETATE essentially The investigators excluded patient with risk factor of meningioma added at hormonal treatment exposition The investigators discribe the caractéristique of patients: age, sex, duration of the treatment, the caractéristique of the meningioma: localization, grade, hormonal receptors, treatment by surgery or radiotherapy and changing after discontinuation of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '6 men/110, 104 women/110 sex ratio 17.5:1 average duration of follow up: 5.5 years average age at diagnosis: 54 +/- 13 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* minimum 18 years\n* medical follow up in CHRU of Brest\n* treated by CYPROTERONE ACETATE and/or CHLORMADINONE ACETATE NOMEGESTROL ACETATE, PROGESTERONE , DYDROGESTERONE PROMEGESTONE , NORETHISTERONE, LEVONORGESTREL , oestroprogestogenic contraception\n* meningioma after treatement by progestin or CYPROTERONE ACETATE\n\nExclusion Criteria:\n\n* history ofbreast cancer\n* history of cerebral radiotherapy\n* history of neurofibromatosis\n* meningioma before treatement by progestin or CYPROTERONE ACETATE\n* minor patient'}, 'identificationModule': {'nctId': 'NCT04109404', 'acronym': 'MAP', 'briefTitle': 'Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin: Retrospective Study in Patients Followed at the CHRU of Brest', 'orgStudyIdInfo': {'id': '29BRC19.0030'}}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Département de Nutrition - CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Véronique KERLAN, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Endocrinologie-Diabétologie - CHRU de Brest"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}