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

NCT07282470 | Active Not Recruiting

• 1 other identifier: MIND
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Meningioma of Brain; Meningioma

Keywords

Meningioma; Machine Learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Validation of epigenetic signature in prospective tissues

  Months 13-18

• Validation of epigenetic biomarkers in circulating nucleosomes

  Months 13-20

• DNA methylation profiling in plasma-EVs

  Months 10-20

• Development of a Machine Learning prognostic classifier

  Months 18-24

Study Arms (2)

Retrospective Cohort

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

Prospective Cohort

60 patients diagnosed with meningioma recruited prospectively.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Meningioma

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tessuti FFPE, siero, plasma, EVs

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: September 25, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)