Clinical trial · Observational
Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meningioma | Meningioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral smears | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- group 1: Exposed to CPA + Meningioma
- description
- Meningioma diagnosed in women by medical imaging examination and confirmed histologically if surgery is performed. Cyproterone acetate taken for at least 6 months.
- interventionNames
- Procedure: oral smears
- label
- group 2: Exposed to CPA without Meningioma
- description
- 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.
- interventionNames
- Procedure: oral smears
- label
- group 3: Not exposed to CPA, Meningioma diagnosed
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available