Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Number of enrolled patients for smear samples
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Number of enrolled patients for smear samples
时间窗: at the end of study, an average of 2 years
Number of enrolled patients in the study with good quality of smear samples.
次要结局
- Occurrence of meningioma in first-degree relatives(at the end of study, an average of 2 years)
- Number of family cases of meningioma(at the end of study, an average of 2 years)
- Occurrence of hormonodependant cancer(at the end of study, an average of 2 years)
- Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma(at baseline)