MeningiomaANDROMEDE-FNCT04372095
Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
An observational study of Meningioma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Meningioma
- What is being tested?
- oral smears
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2021to 19 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult women with or without meningioma either exposed or not to cyproterone acetate.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP
Boulogne-Billancourt, 92100
About this study
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.
Read the 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.
- Conditions
- Meningioma
- Being tested
- oral smears
- Keywords
- meningioma, predisposition, genetic
- Medical subject headings
- Meningioma, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral smearsProcedure or surgery
oral smears
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrolled patients for smear samples
Number of enrolled patients in the study with good quality of smear samples.
Measured: at the end of study, an average of 2 years
Secondary outcomes (4)
Number of family cases of meningioma
Number of family cases of meningioma occurrence will be noted in each group.
Measured: at the end of study, an average of 2 years
Occurrence of meningioma in first-degree relatives
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.
Measured: 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.
Measured: 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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start6 Jul 2021
- Primary completion19 Apr 2025 (estimated)
- Study completion19 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Laure RAFFIN-SANSON, MD, PhD, Principal investigator, Service Endocrinologie Nutrition, Hôpital Ambroise Paré, APHP & EA4340, UFR Santé Simone Veil, Université Paris SaclayMarc SANSON, MD, PhD, Study chair, Equipe Génétique et Développement des Tumeurs Cérébrales, Service Neuro Oncologie, Hôpital Pitié Salpetrière, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372095
- Sponsor's protocol ID
- APHP200222
- Other IDs
- 2020-A00045-34
- Acronym
- ANDROMEDE-F
- Status last verified
- Oct 2023
- First submitted
- 30 Apr 2020
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study
- ClinicalTrials.gov ID
- NCT04372095
- Acronym / sponsor ID
- ANDROMEDE-F / APHP200222
- Conditions
- Meningioma
- Keywords
- meningioma, predisposition, genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 19 Apr 2025 (estimated)
- Study completion
- 19 Apr 2025 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1: Exposed to CPA + Meningioma | – | Procedure: oral smearsMeningioma 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 | – | Procedure: oral smearsWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with or without meningioma either exposed or not to cyproterone acetate.
Key inclusion criteria (15 listed)
- 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.
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral smearsoral smears | Procedure or surgery | group 1: Exposed to CPA + Meningioma, group 2: Exposed to CPA without Meningioma |
Primary outcome
Number of enrolled patients for smear samples
Time frame: at the end of study, an average of 2 years
Number of enrolled patients in the study with good quality of smear samples.
4 secondary outcomes
Number of family cases of meningioma
Time frame: at the end of study, an average of 2 years
Occurrence of meningioma in first-degree relatives
Time frame: at the end of study, an average of 2 years
Occurrence of hormonodependant cancer
Time frame: at the end of study, an average of 2 years
Characteristic of the meningioma : Size, Localization, treatment, evolution of meningioma
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Laure RAFFIN-SANSON, MD, PhD principal investigator
Service Endocrinologie Nutrition, Hôpital Ambroise Paré, APHP & EA4340, UFR Santé Simone Veil, Université Paris Saclay
Marc SANSON, MD, PhD study chair
Equipe Génétique et Développement des Tumeurs Cérébrales, Service Neuro Oncologie, Hôpital Pitié Salpetrière, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Laure RAFFIN-SANSON, MD, PhD (+33 1 49 09 54 95, marie-laure.raffin-sanson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of enrolled patients for smear samples (time frame: at the end of study, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.