NCT05793034

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Jan 2027

Study Start

First participant enrolled

January 7, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2027

Expected
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

February 23, 2023

Last Update Submit

March 11, 2025

Conditions

MeningiomaMeningioma AtypicalAnaplastic Meningioma

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival (RFS)

    Correlation from biomolecular data and RFS

    5 years on average

Secondary Outcomes (1)

  • Overall survival (OS)

    5 years on average

Study Arms (1)

Biological biomarker assessment

OTHER

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

Diagnostic Test: Biological biomarker assessment

Interventions

Biological biomarker assessmentDIAGNOSTIC_TEST

IHC, PCR, NGS, methylome

Biological biomarker assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \) Patient lost at follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Central Study Contacts

Alessandro Olivi, MD

CONTACT

+39 06 3015 4120alessandro.olivi@policlinicogemelli.it

Rina Di Bonaventura, MD

CONTACT

+39 06 3015 1rina.dibonaventura@guest.policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 31, 2023

Study Start

January 7, 2021

Primary Completion

January 7, 2026

Study Completion (Estimated)

January 7, 2027

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

IT(1)