Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-30 @ 11:33 AM
Study NCT ID:
NCT04372095
Status:
UNKNOWN
Last Update Posted:
2023-10-30
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Oral smears: the sampling of oral smears will be collected by subjects themselves at home and sent to the Biological Research Center (CRB) of Neuro-Oncothèque of La Pitie Salpêtrière hospital. Each sampling will be accompanied by an inform consent signed by the patient.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-04-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-27', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of enrolled patients for smear samples', 'timeFrame': 'at the end of study, an average of 2 years', 'description': 'Number of enrolled patients in the study with good quality of smear samples.'}], 'secondaryOutcomes': [{'measure': 'Number of family cases of meningioma', 'timeFrame': 'at the end of study, an average of 2 years', 'description': 'Number of family cases of meningioma occurrence will be noted in each group.'}, {'measure': 'Occurrence of meningioma in first-degree relatives', 'timeFrame': 'at the end of study, an average of 2 years', 'description': 'Number of occurrence of meningioma will be collected for:\n\n* in first-degree relatives of index case in each group.\n* in first-degree relatives exposed to cyproterone acetate in each group.'}, {'measure': 'Occurrence of hormonodependant cancer', 'timeFrame': 'at the end of study, an average of 2 years', 'description': 'Number of hormonodependant cancer occurrence the index case and in first-degree relatives in each group.'}, {'measure': 'Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma', 'timeFrame': 'at baseline', 'description': 'In goups 1 and 3.\n\nSize and Localization of meningioma will be determined by RMI examination.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meningioma', 'predisposition', 'genetic'], 'conditions': ['Meningioma']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to create a biobank of oral smears permitting to identify the genetic locus/loci associated with an increased risk to develop meningiomas after cyproterone acetate (CPA) (Androcur®) treatment, using a GWAS approach.\n\nAs the secondary objectives, the study aims:\n\n* to evaluate the importance of the genetic susceptibility.\n* to record the frequence of homonodependant cancers occuring in female patients with Androcur® associated meningioma and in their first-degree relatives.\n* to describe clinical, radiological, histological characteristics of the patients who have developed meningioma after cyproterone acetate exposure.', 'detailedDescription': 'The increased risk to develop a meningioma has recently been established for patients received the cyproterone acetate.\n\nThe investigators observed several familial cases of CPA related meningiomas which suggest a strong genetic factor modulating the risk to develop meningiomas in patients who exposed to CPA. The aim of this study is to generate a biobank permitting, in future studies, to identify the genetic locus/loci associated with an increased risk to develop meningiomas after CPA (Androcur®) treatment, using a GWAS approach.\n\nEnrollment of patients will occur at hospitals where the patients will be treated and also via social networking sites such as Facebook. There will be 4 groups of subjects. Five hundred patients will be enrolled in each group targeting 2000 patients in total, among which 1000 patients (Groupe 1 and Groupe 2) will participate in the biobank.\n\nSix centers in 5 university hospitals of APHP (Pitié-Salpêtrière, Ambroise Paré, Cochin, Lariboisière, Saint-Antoine) will be involved in the study.\n\nLa duration of enrollment will be 24 months. The participation duration for each subject will be 1 hour. Statistics analysis method: SAS 9.1.3.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women with or without meningioma either exposed or not to cyproterone acetate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ⩾18 years;\n* Non-opposition opinion obtained during the first phone call at the beginning of the study;\n* Covered by the french social security scheme.\n\nFor the group 1:\n\n* Meningioma diagnosed by medical imaging and confirmed histologically if surgery occurred;\n* Cyproterone acetate taken for at least 6 months, 25 mg par day and 20 day by month (cumulated dose ⩾ 3 000mg).\n\nFor the group 2:\n\n* Cyproterone acetate taken for at least 5 years with dose of 50 mg per day and 20 day by month, or a cumulated dose corresponding to a longer period (⩾ 30 000mg);\n* Normal result of RMI examination performed after at least 5 years treatment by cyproterone acetate.\n\nFor the group 3 :\n\n* Subject who has never taken cyproterone acetate;\n* Meningioma diagnosed by medical imaging examination and confirmed histologically if surgery occured.\n\nFor the group 4 :\n\n* Subject who has never taken cyproterone acetate;\n* Subject never diagnosed with meningioma.\n\nExclusion Criteria:\n\n* Subject under tutoraship;\n* Subject refusal;\n* Communication difficulties such as: language barriers, serious problems of hearing without a hearing instrument, cognitive troubles... ;\n* Foreign subject under AME scheme (a french social system).'}, 'identificationModule': {'nctId': 'NCT04372095', 'acronym': 'ANDROMEDE-F', 'briefTitle': 'Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study', 'orgStudyIdInfo': {'id': 'APHP200222'}, 'secondaryIdInfos': [{'id': '2020-A00045-34', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1: Exposed to CPA + Meningioma', 'description': 'Meningioma diagnosed in women by medical imaging examination and confirmed histologically if surgery is performed.\n\nCyproterone acetate taken for at least 6 months.', 'interventionNames': ['Procedure: oral smears']}, {'label': 'group 2: Exposed to CPA without Meningioma', 'description': 'Women exposed to Cyproterone acetate without developing any meningioma Absence of meningioma assessed by a normal cerebral MRI . Cyproterone acetate taken for at least 5 years.', 'interventionNames': ['Procedure: oral smears']}, {'label': 'group 3: Not exposed to CPA, Meningioma diagnosed', 'description': 'Meningioma in women not exposed to cyproterone acetate. Meningioma diagnosed by medical imaging examination and confirmed histologically if surgery was necessary.\n\nNever exposed to cyproterone acetate.'}, {'label': 'group 4: General population', 'description': 'Subjects (women) never diagnosed with meningioma and not exposed to cyproterone acetate.'}], 'interventions': [{'name': 'oral smears', 'type': 'PROCEDURE', 'description': 'oral smears', 'armGroupLabels': ['group 1: Exposed to CPA + Meningioma', 'group 2: Exposed to CPA without Meningioma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}], 'centralContacts': [{'name': 'Marie-Laure RAFFIN-SANSON, MD, PhD', 'role': 'CONTACT', 'email': 'marie-laure.raffin-sanson@aphp.fr', 'phone': '+33 1 49 09 54 95'}, {'name': 'Marc SANSON, MD, PhD', 'role': 'CONTACT', 'email': 'marc.sanson@aphp.fr', 'phone': '+33 1 42 16 04 35'}], 'overallOfficials': [{'name': 'Marie-Laure RAFFIN-SANSON, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service Endocrinologie Nutrition, Hôpital Ambroise Paré, APHP & EA4340, UFR Santé Simone Veil, Université Paris Saclay'}, {'name': 'Marc SANSON, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Equipe Génétique et Développement des Tumeurs Cérébrales, Service Neuro Oncologie, Hôpital Pitié Salpetrière, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}