23Men: Predictive Factors for Survival in Aggressive Meningiomas

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05793034

Collaborator

(none)

250

Enrollment

Location

Arm

35.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meningioma Meningioma Atypical Anaplastic Meningioma	Diagnostic Test: Biological biomarker assessment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Analysis of Predictive Factors for Overall and Progression-free Survival After Neurosurgery for Atypical or Anaplastic Meningioma

Actual Study Start Date :

Jan 7, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Biological biomarker assessment FFPE tumor tissue will be processed with a number of molecular biology techniques	Diagnostic Test: Biological biomarker assessment IHC, PCR, NGS, methylome

Arm

Intervention/Treatment

Other: Biological biomarker assessment

FFPE tumor tissue will be processed with a number of molecular biology techniques

Diagnostic Test: Biological biomarker assessment

IHC, PCR, NGS, methylome

Outcome Measures

Primary Outcome Measures

Recurrence-free survival (RFS) [5 years on average]
Correlation from biomolecular data and RFS

Secondary Outcome Measures

Overall survival (OS) [5 years on average]
Correlation from biomolecular data and OS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion criteria

Patient lost at follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome		Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05793034

Other Study ID Numbers:

3459

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Meningioma

Study Results

No Results Posted as of Mar 31, 2023