NCT07282470

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Meningioma
• Meningioma of Brain

Timeline

• Start date: 2024-09-25
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-12-15
• Last updated: 2026-02-10

Locations

1 site across 1 country: Italy