Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients - MIND (MIND)

Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients

Meningiomas are the most common primary intracranial tumors. Current treatment relies on surgical resection and radiotherapy, but molecular predictors for recurrence are lacking. This study aims to investigate epigenetic features, specifically histone post-translational modifications (PTMs) and DNA methylation, to stratify patients. The study involves a retrospective cohort to define an epigenetic signature and a prospective cohort to validate it in tissues and liquid biopsies (plasma/EVs).

Study Overview

• Status: Recruiting
• Conditions: Meningioma; Meningioma of Brain

Detailed Description

The study is shaped by two phases. The first is a histone PTMs analysis in solid tissues from a retrospective cohort of 150 meningioma FFPE samples. The second step consists of validating the epigenetic signature in a prospective cohort of patients (n=60). The study addresses four main objectives: 1) Dissecting the informative power of epigenetic signatures (histone PTMs by MS) in tissues; 2) Validating signatures in prospective tissues and matched sera (circulating nucleosomes); 3) Assessing DNA methylation profiles from plasma-derived Extracellular Vesicles (EVs); 4) Developing a Machine Learning model integrating epi-proteomics, DNA-methylation, and clinical data for prognostic subtyping.

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Contact: Francesco Di Meco, MD; Phone Number: 2400 + 39 02.2394; Email: francesco.dimeco@istituto-besta.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Meningioma

Description

Inclusion Criteria:

Inclusion Criteria (Retrospective & Prospective):

• Patient aged 18 years or older.
• First diagnosis of uni-focal meningioma of the convexity.
• Macroscopical total resection (Simpson 1-3).

(Retrospective only):

• Surgery performed between 2007 and 2016;
• availability of FFPE sample and medical records.

Exclusion Criteria:

• Genetic syndromes.
• Diffuse Meningeal Meningiomatosis.
• Patients who underwent experimental treatment in neo-adjuvant setting.

(Prospective only):

• Previous surgical/medical treatment for another meningioma;
• positive oncological history (e.g., breast cancer).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective Cohort; 150 patients operated for non-recurrent meningioma between 2008 and 2016.
Prospective Cohort; 60 patients diagnosed with meningioma recruited prospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definition of a novel epigenetic signature based on MS-profiling	Identification of histone post-translational modifications (PTMs) patterns in FFPE tissue samples capable of classifying tumor recurrence.	Months 1-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of epigenetic signature in prospective tissues	Validation of the histone PTMs signature using Mass Spectrometry on FFPE samples from the prospective cohort.	Months 13-18
Validation of epigenetic biomarkers in circulating nucleosomes	Profiling histone PTMs in circulating nucleosomes from patient sera matching the tissues profiled.	Months 13-20
DNA methylation profiling in plasma-EVs	Assessment of genome-wide DNA methylation profile from DNA extracted from plasma-derived Extracellular Vesicles.	Months 10-20
Development of a Machine Learning prognostic classifier	Integration of epi-proteomics data, DNA-methylation profiles, and clinico-pathological information to predict recurrence.	Months 18-24

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Collaborators: University of Milan; Università degli Studi del Piemonte Orientale Amedeo Avogadro

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Meningioma; Machine Learning
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningioma
• Other Study ID Numbers: MIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No