Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
- Conditions
- Meningioma
- Interventions
- Procedure: oral smears
- Registration Number
- NCT04372095
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
As the secondary objectives, the study aims:
* to evaluate the importance of the genetic susceptibility.
* to record the frequence of homonodependant cancers occuring in female patients with Androcur® associated meningioma and in their first-degree relatives.
* to describe clinical, radiological, histological characteristics of the patients who have developed meningioma after cyproterone acetate exposure.
- Detailed Description
The increased risk to develop a meningioma has recently been established for patients received the cyproterone acetate.
The 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.
Enrollment 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.
Six centers in 5 university hospitals of APHP (Pitié-Salpêtrière, Ambroise Paré, Cochin, Lariboisière, Saint-Antoine) will be involved in the study.
La duration of enrollment will be 24 months. The participation duration for each subject will be 1 hour. Statistics analysis method: SAS 9.1.3.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 2000
- Age ⩾18 years;
- Non-opposition opinion obtained during the first phone call at the beginning of the study;
- Covered by the french social security scheme.
For the group 1:
- Meningioma diagnosed by medical imaging and confirmed histologically if surgery occurred;
- Cyproterone acetate taken for at least 6 months, 25 mg par day and 20 day by month (cumulated dose ⩾ 3 000mg).
For the group 2:
- 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);
- Normal result of RMI examination performed after at least 5 years treatment by cyproterone acetate.
For the group 3 :
- Subject who has never taken cyproterone acetate;
- Meningioma diagnosed by medical imaging examination and confirmed histologically if surgery occured.
For the group 4 :
- Subject who has never taken cyproterone acetate;
- Subject never diagnosed with meningioma.
- Subject under tutoraship;
- Subject refusal;
- Communication difficulties such as: language barriers, serious problems of hearing without a hearing instrument, cognitive troubles... ;
- Foreign subject under AME scheme (a french social system).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description group 1: Exposed to CPA + Meningioma oral smears Meningioma diagnosed in women by medical imaging examination and confirmed histologically if surgery is performed. Cyproterone acetate taken for at least 6 months. group 2: Exposed to CPA without Meningioma oral smears 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.
- Primary Outcome Measures
Name Time Method Number of enrolled patients for smear samples at the end of study, an average of 2 years Number of enrolled patients in the study with good quality of smear samples.
- Secondary Outcome Measures
Name Time Method Occurrence of meningioma in first-degree relatives at the end of study, an average of 2 years Number of occurrence of meningioma will be collected for:
* in first-degree relatives of index case in each group.
* in first-degree relatives exposed to cyproterone acetate in each group.Number of family cases of meningioma at the end of study, an average of 2 years Number of family cases of meningioma occurrence will be noted in each group.
Occurrence of hormonodependant cancer at the end of study, an average of 2 years Number of hormonodependant cancer occurrence the index case and in first-degree relatives in each group.
Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma at baseline In goups 1 and 3.
Size and Localization of meningioma will be determined by RMI examination.
Trial Locations
- Locations (1)
Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP
🇫🇷Boulogne-Billancourt, France