Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).