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NCT Number: NCT07282470

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

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).

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Key information

Conditions

Meningioma Central Nervous System Neoplasms Meningeal Neoplasms Meningioma of Brain Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Location status: Recruiting

Location contact

Francesco Di Meco, MD

CONTACT

[email protected]

+ 39 02.2394 ext. 2400

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Definition of a novel epigenetic signature based on MS-profiling

    Time frame: Months 1-12

    Identification of histone post-translational modifications (PTMs) patterns in FFPE tissue samples capable of classifying tumor recurrence.

Secondary outcomes

  1. Validation of epigenetic signature in prospective tissues

    Time frame: Months 13-18

    Validation of the histone PTMs signature using Mass Spectrometry on FFPE samples from the prospective cohort.

  2. Validation of epigenetic biomarkers in circulating nucleosomes

    Time frame: Months 13-20

    Profiling histone PTMs in circulating nucleosomes from patient sera matching the tissues profiled.

  3. DNA methylation profiling in plasma-EVs

    Time frame: Months 10-20

    Assessment of genome-wide DNA methylation profile from DNA extracted from plasma-derived Extracellular Vesicles.

  4. Development of a Machine Learning prognostic classifier

    Time frame: Months 18-24

    Integration of epi-proteomics data, DNA-methylation profiles, and clinico-pathological information to predict recurrence.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • University of Milan
  • Università degli Studi del Piemonte Orientale Amedeo Avogadro

Registry information

Official study title

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

Acronym: MIND

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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