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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP
RECRUITING
Boulogne-billancourt
Contact Information
Primary
Marie-Laure RAFFIN-SANSON, MD, PhD
marie-laure.raffin-sanson@aphp.fr
+33 1 49 09 54 95
Backup
Marc SANSON, MD, PhD
marc.sanson@aphp.fr
+33 1 42 16 04 35
Time Frame
Start Date: 2021-07-06
Estimated Completion Date: 2025-04-19
Participants
Target number of participants: 2000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov