Meningioma23MenNCT05793034
Predictive Factors for Survival in Aggressive Meningiomas
A study testing Biological biomarker assessment in people with Meningioma and Meningioma Atypical, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The investigators plan to collect clinical and molecular data, including ICH, PCR, NGS and methylome, from patients operated on for grade 2 or grade 3 meningioma. The purpose of the study is to identify reliable and easy-to-assess predictive factors for recurrence and survival after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma, Meningioma Atypical, Anaplastic Meningioma
- What is being tested?
- Biological biomarker assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2021to 7 Jan 2027
- Phase
- Interventional
- 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
Who may be able to join
- Patient operated for atypical (grade 2) meningioma; or
- Patient operated for anaplastic (grade 3) meningioma;
- Timeframe for surgery, 1999-2019
Who cannot join
- 1) Patient lost at follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Alessandro Olivi, MD, +39 06 3015 4120, alessandro.olivi@policlinicogemelli.it
Roberto Pallini, MD, PhD, +39 06 3015 5414, roberto.pallini@unicatt.it
About this study
Official title: Analysis of Predictive Factors for Overall and Progression-free Survival After Neurosurgery for Atypical or Anaplastic Meningioma
The investigators plan to collect clinical and molecular data, including ICH, PCR, NGS and methylome, from patients operated on for grade 2 or grade 3 meningioma. The purpose of the study is to identify reliable and easy-to-assess predictive factors for recurrence and survival after surgery.
- Conditions
- Meningioma, Meningioma Atypical, Anaplastic Meningioma
- Being tested
- Biological biomarker assessment
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological biomarker assessmentDiagnostic test
IHC, PCR, NGS, methylome
| Study group | Role | What they receive |
|---|---|---|
| Biological biomarker assessment | Other | FFPE tumor tissue will be processed with a number of molecular biology techniques Receives: Diagnostic Test: Biological biomarker assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival (RFS)
Correlation from biomolecular data and RFS
Measured: 5 years on average
Secondary outcomes (1)
Overall survival (OS)
Correlation from biomolecular data and OS
Measured: 5 years on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start7 Jan 2021
- Primary completion7 Jan 2026 (estimated)
- Study completion7 Jan 2027 (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 Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793034
- Sponsor's protocol ID
- 3459
- Acronym
- 23Men
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Predictive Factors for Overall and Progression-free Survival After Neurosurgery for Atypical or Anaplastic Meningioma
- ClinicalTrials.gov ID
- NCT05793034
- Acronym / sponsor ID
- 23Men / 3459
- Conditions
- Meningioma, Meningioma Atypical, Anaplastic Meningioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 7 Jan 2026 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 31 Mar 2023 (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.
The investigators plan to collect clinical and molecular data, including ICH, PCR, NGS and methylome, from patients operated on for grade 2 or grade 3 meningioma. The purpose of the study is to identify reliable and easy-to-assess predictive factors for recurrence and survival after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological biomarker assessment | Other | Diagnostic Test: Biological biomarker assessmentFFPE tumor tissue will be processed with a number of molecular biology techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient operated for atypical (grade 2) meningioma; or
- Patient operated for anaplastic (grade 3) meningioma;
- Timeframe for surgery, 1999-2019
Key exclusion criteria (1 listed)
- 1) Patient lost at follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological biomarker assessmentIHC, PCR, NGS, methylome | Diagnostic test | Biological biomarker assessment |
Primary outcome
Recurrence-free survival (RFS)
Time frame: 5 years on average
Correlation from biomolecular data and RFS
1 secondary outcome
Overall survival (OS)
Time frame: 5 years on average
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 13 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological biomarker assessment in people with Meningioma and Meningioma Atypical, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. 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?
Contact Alessandro Olivi, MD (+39 06 3015 4120, alessandro.olivi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (RFS) (time frame: 5 years on average). 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 13 Mar 2025; AzTrials last refreshed its copy on 2 Nov 2026.