Predictive Factors for Survival in Aggressive Meningiomas

Not Applicable

Recruiting

• Conditions: Meningioma Atypical; Meningioma; Anaplastic Meningioma
• Interventions: Diagnostic Test: Biological biomarker assessment

• Registration Number: NCT05793034
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-01-07
• Status Verified: 2023-02
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion criteria

1. Patient lost at follow-up

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological biomarker assessment	Biological biomarker assessment	FFPE tumor tissue will be processed with a number of molecular biology techniques

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival (RFS)	5 years on average	Correlation from biomolecular data and RFS

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years on average	Correlation from biomolecular data and OS

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy