Meningiomas and Treatment With CYPROTERONE ACETATE or Pro... | NCT04109404

Studies
Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin

NCT04109404

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Oct 11, 2019Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Meningioma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2019Actual

Primary Completion Date

Jun 1, 2019Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Sep 23, 2019

First Submission Date that Met QC Criteria

Sep 27, 2019

First Posted Date

Sep 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2019

Last Update Posted Date

Oct 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis of meningiomas caracteristics	meningiomas caracteristics in patient treated with CYPROTERONE ACETATE or Progestin description	12 months

Secondary Outcomes

Measure	Description	Time Frame
prescription status of progestogenic treatment	indications, duration of treatment, name and type of treatment	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Véronique KERLAN, PH	Service d'Endocrinologie-Diabétologie - CHRU de Brest	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Département de Nutrition - CHRU de Brest		Brest		29200	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26264069	Background	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.
	Background	S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.

ID	Term
D009380	Neoplasms, Nerve Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009383	Neoplasms, Vascular Tissue