About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 years or older.
First diagnosis of uni-focal meningioma of the convexity.
Macroscopical total resection (Simpson 1-3).
Surgery performed between 2007 and 2016;
Disqualifiers
Genetic syndromes.
Diffuse Meningeal Meningiomatosis.
Patients who underwent experimental treatment in neo-adjuvant setting.
Previous surgical/medical treatment for another meningioma;
Trial population
Patients with Meningioma
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Validation of epigenetic signature in prospective tissues
Validation of the histone PTMs signature using Mass Spectrometry on FFPE samples from the prospective cohort.
Validation of epigenetic biomarkers in circulating nucleosomes
Profiling histone PTMs in circulating nucleosomes from patient sera matching the tissues profiled.
DNA methylation profiling in plasma-EVs
Assessment of genome-wide DNA methylation profile from DNA extracted from plasma-derived Extracellular Vesicles.
Development of a Machine Learning prognostic classifier
Integration of epi-proteomics data, DNA-methylation profiles, and clinico-pathological information to predict recurrence.
Sponsors and contacts
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
University of Milan
Collaborator
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborator