NCT04372095

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningioma

Interventions

Type	Name	Description
PROCEDURE	oral smears	oral smears

Timeline

• Start date: 2021-07-06
• Primary completion: 2025-04-19
• Completion: 2025-04-19
• First posted: 2020-05-01
• Last updated: 2023-10-30

Locations

1 site across 1 country: France