Back to resultsPredictive Factors for Survival in Aggressive Meningiomas (23Men)
Primary Purpose
Meningioma, Meningioma Atypical, Anaplastic Meningioma
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biological biomarker assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Meningioma
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
Sites / Locations
- Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Biological biomarker assessment
Arm Description
FFPE tumor tissue will be processed with a number of molecular biology techniques
Outcomes
Primary Outcome Measures
Recurrence-free survival (RFS)
Correlation from biomolecular data and RFS
Secondary Outcome Measures
Overall survival (OS)
Correlation from biomolecular data and OS
Full Information
NCT ID
NCT05793034
First Posted
February 23, 2023
Last Updated
March 29, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05793034
Brief Title
Predictive Factors for Survival in Aggressive Meningiomas
Acronym
23Men
Official Title
Analysis of Predictive Factors for Overall and Progression-free Survival After Neurosurgery for Atypical or Anaplastic Meningioma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma, Meningioma Atypical, Anaplastic Meningioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological biomarker assessment
Arm Type
Other
Arm Description
FFPE tumor tissue will be processed with a number of molecular biology techniques
Intervention Type
Diagnostic Test
Intervention Name(s)
Biological biomarker assessment
Intervention Description
IHC, PCR, NGS, methylome
Primary Outcome Measure Information:
Title
Recurrence-free survival (RFS)
Description
Correlation from biomolecular data and RFS
Time Frame
5 years on average
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Correlation from biomolecular data and OS
Time Frame
5 years on average
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Olivi, MD
Phone
+39 06 3015 4120
Email
alessandro.olivi@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Rina Di Bonaventura, MD
Phone
+39 06 3015 1
Email
rina.dibonaventura@guest.policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Olivi, MD
Phone
+39 06 3015 4120
Email
alessandro.olivi@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Roberto Pallini, MD, PhD
Phone
+39 06 3015 5414
Email
roberto.pallini@unicatt.it
First Name & Middle Initial & Last Name & Degree
Rina Di Bonaventura, MD
First Name & Middle Initial & Last Name & Degree
Q. Giorgio D'Alessandris, MD
12. IPD Sharing Statement
Learn more about this trial
Predictive Factors for Survival in Aggressive Meningiomas
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