Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients - MIND
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Meningioma, Meningioma of Brain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients
Overview
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.
Primary outcome measures
- Definition of a novel epigenetic signature based on MS-profiling [Time frame: Months 1-12]
Secondary outcome measures (4)
- Validation of epigenetic signature in prospective tissues [Time frame: Months 13-18]
- Validation of epigenetic biomarkers in circulating nucleosomes [Time frame: Months 13-20]
- DNA methylation profiling in plasma-EVs [Time frame: Months 10-20]
- Development of a Machine Learning prognostic classifier [Time frame: Months 18-24]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
Identifiers
NCT: NCT07282470 · MIND