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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00045-34 | Registry Identifier | IDRCB |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral smears | Procedure | oral smears |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of enrolled patients for smear samples | Number of enrolled patients in the study with good quality of smear samples. | at the end of study, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of family cases of meningioma | Number of family cases of meningioma occurrence will be noted in each group. | at the end of study, an average of 2 years |
| Occurrence of meningioma in first-degree relatives |
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Inclusion Criteria:
For the group 1:
For the group 2:
For the group 3 :
For the group 4 :
Exclusion Criteria:
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Adult women with or without meningioma either exposed or not to cyproterone acetate.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Laure RAFFIN-SANSON, MD, PhD | Contact | +33 1 49 09 54 95 | marie-laure.raffin-sanson@aphp.fr | |
| Marc SANSON, MD, PhD | Contact | +33 1 42 16 04 35 | marc.sanson@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Laure RAFFIN-SANSON, MD, PhD | Service Endocrinologie Nutrition, Hôpital Ambroise Paré, APHP & EA4340, UFR Santé Simone Veil, Université Paris Saclay | Principal Investigator |
| Marc SANSON, MD, PhD | Equipe Génétique et Développement des Tumeurs Cérébrales, Service Neuro Oncologie, Hôpital Pitié Salpetrière, APHP |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP | Recruiting | Boulogne-Billancourt | 92100 | France |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| D004198 | Disease Susceptibility |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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Oral smears: the sampling of oral smears will be collected by subjects themselves at home and sent to the Biological Research Center (CRB) of Neuro-Oncothèque of La Pitie Salpêtrière hospital. Each sampling will be accompanied by an inform consent signed by the patient.
Number of occurrence of meningioma will be collected for:
| at the end of study, an average of 2 years |
| Occurrence of hormonodependant cancer | Number of hormonodependant cancer occurrence the index case and in first-degree relatives in each group. | at the end of study, an average of 2 years |
| Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma | In goups 1 and 3. Size and Localization of meningioma will be determined by RMI examination. | at baseline |
| Study Chair |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |