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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 30, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the potential link between the medication Androcur® (Cyproterone Acetate) and the development of meningiomas, which are tumors that can form in the brain. The researchers want to collect samples from patients to understand if certain genetic factors make some women more likely to develop these tumors after taking the medication. They are also interested in recording how often certain types of cancers occur in women who have taken Androcur® and their close family members, as well as looking at the characteristics of those who develop meningiomas after using this treatment.

To participate in this study, women must be at least 18 years old and covered by the French social security system. There are several groups based on their history with Androcur®: one group includes women diagnosed with meningiomas who have taken the medication for at least six months, while another group includes women who have taken it for five years or more but do not have meningiomas. There are also groups for women who have never taken Androcur® but have or have not been diagnosed with meningiomas. Participants can expect to provide oral samples and share their medical history, and the study is currently recruiting participants. It’s important to know that women who have communication difficulties or are under legal guardianship cannot take part in this trial.

Gender

FEMALE

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).