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

NCT04372095 | Unknown

• 2 other identifiers: APHP2002222020-A00045-34
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningioma

Keywords

meningioma; predisposition; genetic

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of family cases of meningioma

  at the end of study, an average of 2 years

• Occurrence of meningioma in first-degree relatives

  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

Study Arms (4)

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.

Procedure: oral smears

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.

Procedure: oral smears

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.

Interventions

oral smears PROCEDURE

oral smears

group 1: Exposed to CPA + Meningioma; group 2: Exposed to CPA without Meningioma

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with or without meningioma either exposed or not to cyproterone acetate.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP

Boulogne-Billancourt, 92100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Meningioma; Disease Susceptibility

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 1, 2020
• Study Start: July 6, 2021
• Primary Completion: April 19, 2025
• Study Completion: April 19, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)