Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2023-11-15

Brief Summary

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The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.

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Detailed Description

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The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial CSF samples (hereafter referred to as initial proteomic profile and initial cytology).

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study process

Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid

Group Type EXPERIMENTAL

Consultation

Intervention Type PROCEDURE

History of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status.

Cerebral and medullary MRI, lumbar puncture, CSF sampling

Intervention Type PROCEDURE

diagnosis of leptomeningeal involvement

biological test

Intervention Type BIOLOGICAL

5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis

Interventions

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Consultation

History of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status.

Intervention Type PROCEDURE

Cerebral and medullary MRI, lumbar puncture, CSF sampling

diagnosis of leptomeningeal involvement

Intervention Type PROCEDURE

biological test

5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient with histologically proven breast cancer;
* Patient with suspected metastatic leptomeningeal involvement;
* Age ≥ 18 ans ;
* WHO performance status ≤ 2 ;
* Affiliation to the National Social Security System ;
* With informed and signed consent

Exclusion Criteria

* History of another cancer than the one for which the patient is referred;
* Contraindication to lumbar puncture or cerebrospinal MRI
* Pregnant or breastfeeding woman

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No