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

NCT ID: NCT07282470

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-25

Study Completion Date

2026-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Meningioma Meningioma of Brain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective Cohort

150 patients operated for non-recurrent meningioma between 2008 and 2016.

No interventions assigned to this group

Prospective Cohort

60 patients diagnosed with meningioma recruited prospectively.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

Università degli Studi del Piemonte Orientale Amedeo Avogadro

OTHER

Sponsor Role collaborator

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Francesco Di Meco, MD

Role: primary

+ 39 02.2394 ext. 2400

Other Identifiers

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MIND

Identifier Type: -

Identifier Source: org_study_id

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