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Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study — ANDROMEDE-F  

Meningioma Clinical Trial

Official title:
Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04372095
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact Marie-Laure RAFFIN-SANSON, MD, PhD
Phone +33 1 49 09 54 95
Email marie-laure.raffin-sanson@aphp.fr
Status Recruiting
Phase
Start date July 6, 2021
Completion date April 19, 2025
View Details
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