Meningioma
Conditions
Keywords
meningioma, predisposition, genetic
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 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.
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 which suggest a strong genetic factor modulating the risk to develop meningiomas in patients who exposed to CPA. The aim of this study is to generate a biobank permitting, in future studies, to identify the genetic locus/loci associated with an increased risk to develop meningiomas after CPA (Androcur®) treatment, using a GWAS approach. Enrollment of patients will occur at hospitals where the patients will be treated and also via social networking sites such as Facebook. There will be 4 groups of subjects. Five hundred patients will be enrolled in each group targeting 2000 patients in total, among which 1000 patients (Groupe 1 and Groupe 2) will participate in the biobank. Six centers in 5 university hospitals of APHP (Pitié-Salpêtrière, Ambroise Paré, Cochin, Lariboisière, Saint-Antoine) will be involved in the study. La duration of enrollment will be 24 months. The participation duration for each subject will be 1 hour. Statistics analysis method: SAS 9.1.3.
Interventions
PROCEDUREoral smears
oral smears
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of enrolled patients for smear samples | at the end of study, an average of 2 years | Number of enrolled patients in the study with good quality of smear samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of family cases of meningioma | at the end of study, an average of 2 years | Number of family cases of meningioma occurrence will be noted in each group. |
| Occurrence of meningioma in first-degree relatives | at the end of study, an average of 2 years | Number of occurrence of meningioma will be collected for: * in first-degree relatives of index case in each group. * in first-degree relatives exposed to cyproterone acetate in each group. |
| Occurrence of hormonodependant cancer | at the end of study, an average of 2 years | Number of hormonodependant cancer occurrence the index case and in first-degree relatives in each group. |
| Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma | at baseline | In goups 1 and 3. Size and Localization of meningioma will be determined by RMI examination. |
Countries
France
Contacts
Primary ContactMarie-Laure RAFFIN-SANSON, MD, PhD
Backup ContactMarc SANSON, MD, PhD
Outcome results
None listed