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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-06

Study Completion Date

2025-04-19

Brief Summary

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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.

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Detailed Description

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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

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Meningioma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1: Exposed to CPA + Meningioma

Meningioma diagnosed in women by medical imaging examination and confirmed histologically if surgery is performed.

Cyproterone acetate taken for at least 6 months.

oral smears

Intervention Type PROCEDURE

oral smears

group 2: Exposed to CPA without Meningioma

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.

oral smears

Intervention Type PROCEDURE

oral smears

group 3: Not exposed to CPA, Meningioma diagnosed

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.

No interventions assigned to this group

group 4: General population

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

No interventions assigned to this group

Interventions

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oral smears

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes