Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin

NCT04109404 | Completed

• 1 other identifier: 29BRC19.0030
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Meningioma

Keywords

meningioma,; progestin,; cyproterone acetate

Outcome Measures

Primary Outcomes (1)

• Diagnosis of meningiomas caracteristics

  meningiomas caracteristics in patient treated with CYPROTERONE ACETATE or Progestin description

  12 months

Secondary Outcomes (1)

• prescription status of progestogenic treatment

  12 months

Eligibility Criteria

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

Study Population

6 men/110, 104 women/110 sex ratio 17.5:1 average duration of follow up: 5.5 years average age at diagnosis: 54 +/- 13 years

You may qualify if:

• 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

You may not qualify if:

• history ofbreast cancer
• history of cerebral radiotherapy
• history of neurofibromatosis
• meningioma before treatement by progestin or CYPROTERONE ACETATE
• minor patient

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Département de Nutrition - CHRU de Brest

Brest, 29200, France

Location

Related Publications (2)

• 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.

  PMID: 26264069 BACKGROUND

• S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.

  BACKGROUND

MeSH Terms

Conditions

Meningioma

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

Study Officials

• Véronique KERLAN, PH

  Service d'Endocrinologie-Diabétologie - CHRU de Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 30, 2019
• Study Start: February 25, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-09

Locations

FR (1)