Meningioma Clinical Trial
— MAPOfficial title:
Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin: Retrospective Study in Patients Followed at the CHRU of Brest
NCT number | NCT04109404 |
Other study ID # | 29BRC19.0030 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 25, 2019 |
Est. completion date | June 1, 2019 |
Verified date | September 2019 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest
Status | Completed |
Enrollment | 110 |
Est. completion date | June 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - minimum 18 years - medical follow up in CHRU of Brest - treated by CYPROTERONE ACETATE and/or CHLORMADINONE ACETATE NOMEGESTROL ACETATE, PROGESTERONE , DYDROGESTERONE PROMEGESTONE , NORETHISTERONE, LEVONORGESTREL , oestroprogestogenic contraception - meningioma after treatement by progestin or CYPROTERONE ACETATE Exclusion Criteria: - history ofbreast cancer - history of cerebral radiotherapy - history of neurofibromatosis - meningioma before treatement by progestin or CYPROTERONE ACETATE - minor patient |
Country | Name | City | State |
---|---|---|---|
France | Département de Nutrition - CHRU de Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Bernat AL, Oyama K, Hamdi S, Mandonnet E, Vexiau D, Pocard M, George B, Froelich S. Growth stabilization and regression of meningiomas after discontinuation of cyproterone acetate: a case series of 12 patients. Acta Neurochir (Wien). 2015 Oct;157(10):1741-6. doi: 10.1007/s00701-015-2532-3. Epub 2015 Aug 12. — View Citation
S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of meningiomas caracteristics | meningiomas caracteristics in patient treated with CYPROTERONE ACETATE or Progestin description | 12 months | |
Secondary | prescription status of progestogenic treatment | indications, duration of treatment, name and type of treatment | 12 months |
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