MeningiomaMEMENCT05821790
Role of the Tumor Microenvironment in Aggressive Meningiomas
An observational study of Meningioma, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Meningiomas are the most common primary tumors of the central nervous system in adults. High-grade forms have a high frequency of neurofibromatosis 2 (NF2) mutations and represent 25% of meningiomas, with multiple recurrences associated with morbidity and reduced survival without medical options, including… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Surgical waste and Data collect
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who underwent surgery for the resection of a meningioma
Who may be able to join
- Patients who underwent surgery for the resection of a meningioma.
- Patients with meningiomas located at the convexity and parasagittal regions.
- Patients aged 18 years or older.
- Patients who were informed of the study and did not express opposition to their participation.
Who cannot join
- Individuals under legal protection (guardianship, trusteeship) safeguarded by justice
Trial locations and contacts
No sites are listed yet.
About this study
Meningiomas are the most common primary tumors of the central nervous system in adults. High-grade forms have a high frequency of neurofibromatosis 2 (NF2) mutations and represent 25% of meningiomas, with multiple recurrences associated with morbidity and reduced survival without medical options, including immunotherapy. The meninges play a key role in neuro-immune communication through the diversity of their immune cells and the presence of meningeal lymphatic vessels (MLV). Recent data, including from our team, shows frequent infiltration of lymphocytes and myeloid cells specific to benign meningiomas. Our hypothesis is that the immune microenvironment composed of meningeal immune cells and MLVs regulates the malignant histological progression of NF2-mutated meningiomas and their immune surveillance evasion behavior This study aims to characterize the different cellular populations of the meningioma microenvironment. We will describe the exact participation of immune and vascular cell populations in the initiation and progression of meningioma, using MRI imaging and surgical biopsies of the dura mater and meningioma in patients undergoing neurosurgery for meningioma resection.
Read the detailed description
The objective of this study is to characterize the different cellular populations of the microenvironment of meningioma, particularly the immune and vascular cell populations, in order to better understand their role in the initiation and progression of this tumor. For this purpose, we will use MRI imaging and surgical biopsies of the dura mater and meningioma to characterize cellular phenotypes and their interactions in the tissue microenvironment. The research will be conducted on a cohort of patients treated for meningioma in neurosurgery services. Samples required for the study will be obtained from surgical waste of patients who underwent meningioma resection. Data necessary for the study will be collected from the patient's medical records, MRI examinations, and data specific to the characteristics of the surgical waste. Prospective patients will be informed of the study through an information note. Patients who do not object to their participation will undergo neurosurgery intervention in accordance with the usual service protocol. During the intervention, surgical waste will be produced, including the meningioma and adjacent dura mater, which will be collected under the responsibility of the neuro-pathologist who will also take fragments for routine diagnostic histological analysis. We will then perform a targeted mutational analysis associated with neuropathological evaluation of the tumor grade in order to select 10 cases of grade I meningioma and 10 cases of grade II and III meningioma carrying the NF2 mutation. An in-depth analysis will then be carried out on these samples using 10x Genomic's single-cell RNA sequencing (scRNA-seq) technology. This analysis will help to understand the tumor's heterogeneity and establish the phenotype and differentiation trajectory of tumor cells, dura mater cells, and associated immune cells. In addition to RNA analysis, the expression of genetic signatures will be validated by RNAscope tests, while Hyperion imaging will allow visualization of the interrelationships between different types of cells and their spatial distribution. The iDISCO+ immunolabeling combined with three-dimensional fluorescence microscopy imaging will enable visualization of specific protein expression profiles of meningioma and dura mater cell types in 3D. Once the analyses are complete, meningioma and dura mater samples will be destroyed. Preoperative MRI images will also be retrieved and analyzed.
- Conditions
- Meningioma
- Being tested
- Surgical waste and Data collect
- Keywords
- meningioma, meningeal lymphatic vessels, NF2, meningeal micro-environment, immune cells, neurosurgery
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical waste and Data collectOther
Samples required for the study will be obtained from surgical waste of patients who underwent meningioma resection. Data necessary for the study will be collected from the patient's medical records, MRI examinations, and data specific to the characteristics of the surgical waste.
| Study group | Role | What they receive |
|---|---|---|
| patients treated for meningioma | Samples required for the study will be obtained from surgical waste of patients who underwent meningioma resection. Receives: Other: Surgical waste and Data collect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular phenotypes and their interactions in the tissue microenvironment
Characterized by combining different techniques and analysis systems (RNA-seq, RNAScope, Hyperion, Hyperion immunostaining) using samples from various grades of meningiomas and associated dura mater
Measured: one day
Secondary outcomes (5)
Expressed genes in meningioma
Differential expression and gene ontology of expressed genes in meningioma cells, dura mater cells, and associated immune cells, obtained through scRNA-seq and RNAscope analyses using samples from various grades of meningiomas and dura mater
Measured: one day
cell types and spatial distribution
The cell types and their spatial distribution in meningiomas and associated dura mater characterized by the Hyperion cellular imaging system
Measured: One day
Visualization of interrelations in the spatial context
Using the Hyperion cellular imaging system
Measured: One day
3D protein expression
Specific 3D protein expression profiles of cell type in meningiomas and associated dura mater obtained through iDISCO+ immunolabeling combined with fluorescence microscopy imaging
Measured: One day
Three-dimensional reconstruction
Three-dimensional reconstruction of the lymphatic vessels and their cervical lymph nodes associated with pre-surgery MRI data.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Paris Brain Institute (ICM), Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
- Investigators
- Michel KALAMARIDES, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821790
- Sponsor's protocol ID
- APHP230289
- Acronym
- MEME
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 20 Apr 2023
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Tumor Microenvironment in Aggressive Meningiomas
- ClinicalTrials.gov ID
- NCT05821790
- Acronym / sponsor ID
- MEME / APHP230289
- Conditions
- Meningioma
- Keywords
- meningioma, meningeal lymphatic vessels, NF2, meningeal micro-environment, immune cells, neurosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Paris Brain Institute (ICM), Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 20 Apr 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.
Meningiomas are the most common primary tumors of the central nervous system in adults. High-grade forms have a high frequency of neurofibromatosis 2 (NF2) mutations and represent 25% of meningiomas, with multiple recurrences associated with morbidity and reduced survival without medical options, including immunotherapy. The meninges play a key role in neuro-immune communication through the diversity of their immune cells and the presence of meningeal lymphatic vessels (MLV). Recent data, including from our team, shows frequent infiltration of lymphocytes and myeloid cells specific to benign meningiomas. Our hypothesis is that the immune microenvironment composed of meningeal immune cells and MLVs regulates the malignant histological progression of NF2-mutated meningiomas and their immune surveillance evasion behavior This study aims to characterize the different cellular populations of the meningioma microenvironment. We will describe the exact participation of immune and vascular cell populations in the initiation and progression of meningioma, using MRI imaging and surgical biopsies of the dura mater and meningioma in patients undergoing neurosurgery for meningioma resection.
Detailed description
The objective of this study is to characterize the different cellular populations of the microenvironment of meningioma, particularly the immune and vascular cell populations, in order to better understand their role in the initiation and progression of this tumor. For this purpose, we will use MRI imaging and surgical biopsies of the dura mater and meningioma to characterize cellular phenotypes and their interactions in the tissue microenvironment. The research will be conducted on a cohort of patients treated for meningioma in neurosurgery services. Samples required for the study will be obtained from surgical waste of patients who underwent meningioma resection. Data necessary for the study will be collected from the patient's medical records, MRI examinations, and data specific to the characteristics of the surgical waste. Prospective patients will be informed of the study through an information note. Patients who do not object to their participation will undergo neurosurgery intervention in accordance with the usual service protocol. During the intervention, surgical waste will be produced, including the meningioma and adjacent dura mater, which will be collected under the responsibility of the neuro-pathologist who will also take fragments for routine diagnostic histological analysis. We will then perform a targeted mutational analysis associated with neuropathological evaluation of the tumor grade in order to select 10 cases of grade I meningioma and 10 cases of grade II and III meningioma carrying the NF2 mutation. An in-depth analysis will then be carried out on these samples using 10x Genomic's single-cell RNA sequencing (scRNA-seq) technology. This analysis will help to understand the tumor's heterogeneity and establish the phenotype and differentiation trajectory of tumor cells, dura mater cells, and associated immune cells. In addition to RNA analysis, the expression of genetic signatures will be validated by RNAscope tests, while Hyperion imaging will allow visualization of the interrelationships between different types of cells and their spatial distribution. The iDISCO+ immunolabeling combined with three-dimensional fluorescence microscopy imaging will enable visualization of specific protein expression profiles of meningioma and dura mater cell types in 3D. Once the analyses are complete, meningioma and dura mater samples will be destroyed. Preoperative MRI images will also be retrieved and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated for meningioma | – | Other: Surgical waste and Data collectSamples required for the study will be obtained from surgical waste of patients who underwent meningioma resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery for the resection of a meningioma
Key inclusion criteria (4 listed)
- Patients who underwent surgery for the resection of a meningioma.
- Patients with meningiomas located at the convexity and parasagittal regions.
- Patients aged 18 years or older.
- Patients who were informed of the study and did not express opposition to their participation.
Key exclusion criteria (1 listed)
- Individuals under legal protection (guardianship, trusteeship) safeguarded by justice
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 |
|---|---|---|
| Surgical waste and Data collectSamples required for the study will be obtained from surgical waste of patients who underwent meningioma resection. Data necessary for the study will be collected from the patient's medical records, MRI examinations, and data specific to the characteristics of the surgical waste. | Other | patients treated for meningioma |
Primary outcome
Cellular phenotypes and their interactions in the tissue microenvironment
Time frame: one day
Characterized by combining different techniques and analysis systems (RNA-seq, RNAScope, Hyperion, Hyperion immunostaining) using samples from various grades of meningiomas and associated dura mater
5 secondary outcomes
Expressed genes in meningioma
Time frame: one day
cell types and spatial distribution
Time frame: One day
Visualization of interrelations in the spatial context
Time frame: One day
3D protein expression
Time frame: One day
Three-dimensional reconstruction
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michel KALAMARIDES, MD principal investigator
APHP
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma, run by Assistance Publique - Hôpitaux de Paris.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel KALAMARIDES, MD (1 42 16 31 12 ext. 33, michel.kalamarides@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cellular phenotypes and their interactions in the tissue microenvironment (time frame: one day). 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 20 Apr 2023.