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MAP: Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT04109404
Collaborator
(none)
110
Enrollment
1
Location
3.2
Actual Duration (Months)
34.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective study in CHRU of brest, the investigators selected patient with history of méningioma and treated by CYPROTERONE ACETATE, CHLORMADINONE ACETATE and NOMEGESTROL ACETATE essentially The investigators excluded patient with risk factor of meningioma added at hormonal treatment exposition The investigators discribe the caractéristique of patients: age, sex, duration of the treatment, the caractéristique of the meningioma: localization, grade, hormonal receptors, treatment by surgery or radiotherapy and changing after discontinuation of treatment

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin: Retrospective Study in Patients Followed at the CHRU of Brest
    Actual Study Start Date :
    Feb 25, 2019
    Actual Primary Completion Date :
    Jun 1, 2019
    Actual Study Completion Date :
    Jun 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis of meningiomas caracteristics [12 months]

      meningiomas caracteristics in patient treated with CYPROTERONE ACETATE or Progestin description

    Secondary Outcome Measures

    1. prescription status of progestogenic treatment [12 months]

      indications, duration of treatment, name and type of treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Département de Nutrition - CHRU de Brest Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    • Principal Investigator: Véronique KERLAN, PH, Service d'Endocrinologie-Diabétologie - CHRU de Brest

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04109404
    Other Study ID Numbers:
    • 29BRC19.0030
    First Posted:
    Sep 30, 2019
    Last Update Posted:
    Oct 11, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    meningioma,
    progestin,
    cyproterone acetate
    Additional relevant MeSH terms:
    Meningioma

    Study Results

    No Results Posted as of Oct 11, 2019