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NCT05793034 Clinical Trial

Predictive Factors for Survival in Aggressive Meningiomas

Meningioma Clinical Trial

— 23Men  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05793034
Other study ID # 3459
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 7, 2021
Est. completion date December 31, 2023

Study information
Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Alessandro Olivi, MD
Phone +39 06 3015 4120
Email alessandro.olivi@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Biological biomarker assessment
IHC, PCR, NGS, methylome

Locations
Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Rome

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence-free survival (RFS) Correlation from biomolecular data and RFS 5 years on average
Secondary Overall survival (OS) Correlation from biomolecular data and OS 5 years on average
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