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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04372095
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marie-Laure RAFFIN-SANSON, MD, PhDMarc SANSON, MD, PhD
Principal Investigator Affiliation	Service Endocrinologie Nutrition, Hôpital Ambroise Paré, APHP & EA4340, UFR Santé Simone Veil, Université Paris SaclayEquipe Génétique et Développement des Tumeurs Cérébrales, Service Neuro Oncologie, Hôpital Pitié Salpetrière, APHP
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Meningioma

Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

: 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.

: group 4: General population

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

Interventions

Procedure: - oral smears

oral smears

Contact a Trial Team

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