androcur® (cyproterone acetate) and meningioma development: a genotype-environment association study

Conditions: Meningioma

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.

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 criteria:
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).

Keywords: meningioma predisposition genetic