Status:
UNKNOWN
Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Meningioma
Eligibility:
FEMALE
18+ years
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 acetat...
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 19 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04372095
Start Date
July 6 2021
End Date
April 19 2025
Last Update
October 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, France, 92100