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Trial Title:
Role of the Tumor Microenvironment in Aggressive Meningiomas
NCT ID:
NCT05821790
Condition:
Meningioma
Conditions: Official terms:
Meningioma
Conditions: Keywords:
meningioma
meningeal lymphatic vessels
NF2
meningeal micro-environment
immune cells
neurosurgery
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Surgical waste and Data collect
Description:
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.
Arm group label:
patients treated for meningioma
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 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.
Criteria for eligibility:
Study pop:
Patients who underwent surgery for the resection of a meningioma
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Patients who underwent surgery for the resection of a meningioma.
2. Patients with meningiomas located at the convexity and parasagittal regions.
3. Patients aged 18 years or older.
4. Patients who were informed of the study and did not express opposition to their
participation.
Exclusion Criteria:
- Individuals under legal protection (guardianship, trusteeship) safeguarded by
justice
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 2023
Completion date:
May 2024
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
Paris Brain Institute
Agency class:
Other
Collaborator:
Agency:
Gustave Roussy, Cancer Campus, Grand Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05821790