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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

210 Participants
are grouped into 2 trial groups
Group A: Retrospective Cohort
Group B: Prospective Cohort

Trial outcomes

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.

Time frame
Months 1-12

Secondary outcomes

1

Validation of epigenetic signature in prospective tissues

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

Time frame
Months 13-18
2

Validation of epigenetic biomarkers in circulating nucleosomes

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

Time frame
Months 13-20
3

DNA methylation profiling in plasma-EVs

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

Time frame
Months 10-20
4

Development of a Machine Learning prognostic classifier

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

Time frame
Months 18-24

Other outcomes

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