MeningiomaMINDNCT07282470
Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients - MIND
An observational study of Meningioma and Meningioma of Brain, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
Meningiomas are the most common primary intracranial tumors. Current treatment relies on surgical resection and radiotherapy, but molecular predictors for recurrence are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma, Meningioma of Brain
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Meningioma
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients
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).
Read the 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
- Keywords
- Meningioma, Machine Learning
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | 150 patients operated for non-recurrent meningioma between 2008 and 2016. | |
| Prospective Cohort | 60 patients diagnosed with meningioma recruited prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Months 1-12
Secondary outcomes (4)
Validation of epigenetic signature in prospective tissues
Validation of the histone PTMs signature using Mass Spectrometry on FFPE samples from the prospective cohort.
Measured: Months 13-18
Validation of epigenetic biomarkers in circulating nucleosomes
Profiling histone PTMs in circulating nucleosomes from patient sera matching the tissues profiled.
Measured: Months 13-20
DNA methylation profiling in plasma-EVs
Assessment of genome-wide DNA methylation profile from DNA extracted from plasma-derived Extracellular Vesicles.
Measured: Months 10-20
Development of a Machine Learning prognostic classifier
Integration of epi-proteomics data, DNA-methylation profiles, and clinico-pathological information to predict recurrence.
Measured: Months 18-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start25 Sep 2024
- Primary completion31 Mar 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282470
- Sponsor's protocol ID
- MIND
- Acronym
- MIND
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Profiling and Liquid Biopsy: Perspectives for Personalized Medicine in Meningioma Patients
- ClinicalTrials.gov ID
- NCT07282470
- Acronym / sponsor ID
- MIND / MIND
- Conditions
- Meningioma, Meningioma of Brain
- Keywords
- Meningioma, Machine Learning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- University of Milan, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –150 patients operated for non-recurrent meningioma between 2008 and 2016. |
| Prospective Cohort | – | –60 patients diagnosed with meningioma recruited prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Meningioma
Key inclusion criteria (6 listed)
- 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;
- availability of FFPE sample and medical records.
Key exclusion criteria (6 listed)
- Genetic syndromes.
- Diffuse Meningeal Meningiomatosis.
- Patients who underwent experimental treatment in neo-adjuvant setting.
- Previous surgical/medical treatment for another meningioma;
- positive oncological history (e.g., breast cancer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Definition of a novel epigenetic signature based on MS-profiling
Time frame: Months 1-12
Identification of histone post-translational modifications (PTMs) patterns in FFPE tissue samples capable of classifying tumor recurrence.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Meningioma
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Intracranial Meningioma, Recurrent Meningioma
Active, not recruitingPhase 1
Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas
Meningioma
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingPhase 2
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
Meningioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma and Meningioma of Brain, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definition of a novel epigenetic signature based on MS-profiling (time frame: Months 1-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.