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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Meningioma

Treatments: Procedure: oral smears

Study type: Observational

Funder types: Other

Identifiers

NCT04372095

2020-A00045-34 (Registry Identifier)

APHP200222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

2,000 participants in 4 patient groups

group 1: Exposed to CPA + Meningioma

Description:

Meningioma diagnosed in women by medical imaging examination and confirmed histologically if surgery is performed. Cyproterone acetate taken for at least 6 months.

Treatment:

Procedure: oral smears

group 2: Exposed to CPA without Meningioma

Description:

Women exposed to Cyproterone acetate without developing any meningioma Absence of meningioma assessed by a normal cerebral MRI . Cyproterone acetate taken for at least 5 years.

Treatment:

Procedure: oral smears

group 3: Not exposed to CPA, Meningioma diagnosed

Description:

Meningioma in women not exposed to cyproterone acetate. Meningioma diagnosed by medical imaging examination and confirmed histologically if surgery was necessary. Never exposed to cyproterone acetate.

group 4: General population

Description:

Subjects (women) never diagnosed with meningioma and not exposed to cyproterone acetate.