Clinical trial NCT04372095: Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
Official title: Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meningioma
Keywords: meningioma
predisposition
genetic
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with or without meningioma either exposed or not to cyproterone acetate.

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of enrolled patients for smear samples
timeFrame: at the end of study, an average of 2 years
Secondary outcomes:
measure: Number of family cases of meningioma
timeFrame: at the end of study, an average of 2 years
measure: Occurrence of meningioma in first-degree relatives
timeFrame: at the end of study, an average of 2 years
measure: Occurrence of hormonodependant cancer
timeFrame: at the end of study, an average of 2 years
measure: Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma
timeFrame: at baseline
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP
Study officials:
affiliation: Service Endocrinologie Nutrition, Hôpital Ambroise Paré, APHP & EA4340, UFR Santé Simone Veil, Université Paris Saclay
name: Marie-Laure RAFFIN-SANSON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Equipe Génétique et Développement des Tumeurs Cérébrales, Service Neuro Oncologie, Hôpital Pitié Salpetrière, APHP
name: Marc SANSON, MD, PhD
role: STUDY_CHAIR
References: