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

Last updated: October 27, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Tumor

Brain Cancer

Treatment

oral smears

Clinical Study ID

NCT04372095
APHP200222
2020-A00045-34
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ⩾18 years;
  • Non-opposition opinion obtained during the first phone call at the beginning of thestudy;
  • Covered by the french social security scheme. For the group 1:
  • Meningioma diagnosed by medical imaging and confirmed histologically if surgeryoccurred;
  • 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 dayby month, or a cumulated dose corresponding to a longer period (⩾ 30 000mg);
  • Normal result of RMI examination performed after at least 5 years treatment bycyproterone acetate. For the group 3 :
  • Subject who has never taken cyproterone acetate;
  • Meningioma diagnosed by medical imaging examination and confirmed histologically ifsurgery occured. For the group 4 :
  • Subject who has never taken cyproterone acetate;
  • Subject never diagnosed with meningioma.

Exclusion

Exclusion Criteria:

  • Subject under tutoraship;
  • Subject refusal;
  • Communication difficulties such as: language barriers, serious problems of hearingwithout a hearing instrument, cognitive troubles... ;
  • Foreign subject under AME scheme (a french social system).

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: oral smears
Phase:
Study Start date:
July 06, 2021
Estimated Completion Date:
April 19, 2025

Study 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.

Connect with a study center

  • Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

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