Predictive Factors for Survival in Aggressive Meningiomas | NCT05793034

Studies
Predictive Factors for Survival in Aggressive Meningiomas

NCT05793034

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Recruiting

Last Update Posted

Mar 13, 2025Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Meningioma
Meningioma Atypical
Anaplastic Meningioma

Interventions

Biological biomarker assessment

Countries

Italy

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2021Actual

Primary Completion Date

Jan 7, 2026Estimated

Completion Date

Jan 7, 2027Estimated

First Submitted Date

Feb 23, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Mar 31, 2023Actual

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

Mar 11, 2025

Last Update Posted Date

Mar 13, 2025Actual

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

The investigators plan to collect clinical and molecular data, including ICH, PCR, NGS and methylome, from patients operated on for grade 2 or grade 3 meningioma. The purpose of the study is to identify reliable and easy-to-assess predictive factors for recurrence and survival after surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological biomarker assessment	Other	FFPE tumor tissue will be processed with a number of molecular biology techniques	Diagnostic Test: Biological biomarker assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological biomarker assessment	Diagnostic Test	IHC, PCR, NGS, methylome	Biological biomarker assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence-free survival (RFS)	Correlation from biomolecular data and RFS	5 years on average

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	Correlation from biomolecular data and OS	5 years on average

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient operated for atypical (grade 2) meningioma; or
Patient operated for anaplastic (grade 3) meningioma;
Timeframe for surgery, 1999-2019

Exclusion criteria

1) Patient lost at follow-up

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alessandro Olivi, MD	Contact	+39 06 3015 4120		alessandro.olivi@policlinicogemelli.it
Rina Di Bonaventura, MD	Contact	+39 06 3015 1		rina.dibonaventura@guest.policlinicogemelli.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario A. Gemelli IRCCS	Recruiting	Rome		00168	Italy

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