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

  • STATUS
    Recruiting
  • End date
    Aug 9, 2023
  • participants needed
    2000
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 10 October 2021
x-rays
cyproterone acetate
Accepts healthy volunteers

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.

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 (Piti-Salptrire, Ambroise Par, Cochin, Lariboisire, 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.

Details
Condition Meningioma, Meningiomas
Treatment oral smears
Clinical Study IdentifierNCT04372095
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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)
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