NCT05821790

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 7, 2023

Last Update Submit

April 7, 2023

Conditions

Keywords

meningiomameningeal lymphatic vesselsNF2meningeal micro-environmentimmune cellsneurosurgery

Outcome Measures

Primary Outcomes (1)

  • 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

    one day

Secondary Outcomes (5)

  • Expressed genes in meningioma

    one day

  • cell types and spatial distribution

    One day

  • Visualization of interrelations in the spatial context

    One day

  • 3D protein expression

    One day

  • Three-dimensional reconstruction

    One day

Study Arms (1)

patients treated for meningioma

Samples required for the study will be obtained from surgical waste of patients who underwent meningioma resection.

Other: Surgical waste and Data collect

Interventions

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.

patients treated for meningioma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent surgery for the resection of a meningioma

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals under legal protection (guardianship, trusteeship) safeguarded by justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Study Officials

  • Michel KALAMARIDES, MD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel KALAMARIDES, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 20, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share