Sphenoorbital Meningioma Management. | NCT04710485

Studies
Sphenoorbital Meningioma Management.

NCT04710485

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jan 14, 2021Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

Brain Meningioma

Interventions

Not provided

Countries

Not provided

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2021Estimated

Primary Completion Date

Dec 20, 2022Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Jan 12, 2021

First Submission Date that Met QC Criteria

Jan 13, 2021

First Posted Date

Jan 14, 2021Actual

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

Jan 13, 2021

Last Update Posted Date

Jan 14, 2021Actual

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 will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours.

Detailed Description

Not provided

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

24Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical assessment for vision.	With visual acuity examination	For 6 months
Clinical assessment for proptosis	With proptosis index	For 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients who have spheno_orbital meningioma with proptosis and candidate for surgery.

Exclusion Criteria:

all patients have proptosis caused by other lesions than spheno_orbital meningioma.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Any patient candidate for surgery will be included in our study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mostafa Mk Kashef, Assistant lecturer	Contact	01012962093		mostafakashef99@gmail.com

Overall Officials

Name	Affiliation	Role
Assiut Au University	Assiut University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008579	Meningioma

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided