Investigating the link between Cyproterone Acetate and meningioma development

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

This study is trying to see if there’s a connection between a medication called Cyproterone Acetate and the risk of developing meningiomas in patients who have taken it.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Boulogne-Billancourt)
• Trial ID: NCT04372095 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a biobank of oral smears to identify genetic factors associated with an increased risk of developing meningiomas in patients treated with Cyproterone Acetate (Androcur®). The study will enroll 2000 patients across five university hospitals, focusing on those with a history of CPA treatment and meningioma diagnosis. It will also evaluate the frequency of hormone-dependent cancers in affected patients and their relatives, while documenting clinical and radiological characteristics of the cases. The study employs a genome-wide association study (GWAS) approach to analyze genetic susceptibility.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have been treated with Cyproterone Acetate and have either been diagnosed with meningioma or have a significant treatment history.

Not a fit: Patients who have never taken Cyproterone Acetate and do not have a diagnosis of meningioma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and identification of genetic predispositions to meningioma in patients treated with Cyproterone Acetate, potentially guiding future preventive strategies.

How similar studies have performed: While the association between Cyproterone Acetate and meningioma has been noted, this specific genotype-environment association approach is novel and has not been extensively tested in prior studies.

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).

Where this trial is running

Boulogne-Billancourt

• Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP — Boulogne-Billancourt, France (Recruiting)

Study contacts

• Principal investigator: Marie-Laure RAFFIN-SANSON, MD, PhD — Service Endocrinologie Nutrition, Hôpital Ambroise Paré, APHP & EA4340, UFR Santé Simone Veil, Université Paris Saclay
• Study coordinator: Marie-Laure RAFFIN-SANSON, MD, PhD

Conditions Meningioma; meningioma; predisposition; genetic