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

Meningioma Clinical Trial

— ANDROMEDE-F  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04372095
• Other study ID #: APHP200222
• Secondary ID: 2020-A00045-34
• Status: Recruiting
• Start date: July 6, 2021
• Est. completion date: April 19, 2025

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie-Laure RAFFIN-SANSON, MD, PhD
• Phone: +33 1 49 09 54 95
• Email: marie-laure.raffin-sanson[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 19, 2025
• Est. primary completion date: April 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Meningioma

Intervention

Procedure:
• oral smears
oral smears

Locations

Country	Name	City	State
France	Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of enrolled patients for smear samples	Number of enrolled patients in the study with good quality of smear samples.	at the end of study, an average of 2 years
Secondary	Number of family cases of meningioma	Number of family cases of meningioma occurrence will be noted in each group.	at the end of study, an average of 2 years
Secondary	Occurrence of meningioma in first-degree relatives	Number of occurrence of meningioma will be collected for: in first-degree relatives of index case in each group.; in first-degree relatives exposed to cyproterone acetate in each group.	at the end of study, an average of 2 years
Secondary	Occurrence of hormonodependant cancer	Number of hormonodependant cancer occurrence the index case and in first-degree relatives in each group.	at the end of study, an average of 2 years
Secondary	Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma	In goups 1 and 3.; Size and Localization of meningioma will be determined by RMI examination.	at baseline