Epigenetic and liquid‑biopsy profiling to personalize care for meningioma of the brain
Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients
This project will test whether tumor epigenetic patterns and blood-based markers can help predict recurrence and subtype risk in adults with convexity meningioma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07282470 on ClinicalTrials.gov |
What this trial studies
The project uses a two-phase design: first, mass-spectrometry analysis of histone post-translational modifications on 150 retrospective FFPE meningioma samples to identify an epigenetic signature. Second, the signature will be validated prospectively in about 60 patients using matched tumor tissue and blood-derived materials (circulating nucleosomes and extracellular vesicle DNA methylation). The team will integrate epi-proteomics, DNA methylation, and clinical data into a machine learning model to generate prognostic subtypes. The goal is to determine whether tissue and liquid‑biopsy markers can stratify recurrence risk and complement current surgical and radiotherapy decisions.
Who should consider this trial
Good fit: Adults (18+) with a first diagnosis of uni‑focal convexity meningioma who underwent macroscopically total resection (Simpson grades 1–3) and (for prospective enrollment) can provide blood samples and follow-up at the study site.
Not a fit: Patients with genetic syndromes, diffuse meningeal meningiomatosis, prior experimental neoadjuvant treatment, multifocal/non‑convexity tumors, or certain active oncologic histories are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could allow more accurate prediction of recurrence and enable more personalized follow-up and treatment decisions using tissue and blood tests.
How similar studies have performed: DNA methylation profiling has already improved CNS tumor classification in other settings, but combining histone PTM epi‑proteomics with EV DNA methylation and liquid biopsy is a relatively novel and less tested approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.