Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)

Centre Oscar Lambret

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Consultation; Procedure: Cerebral and medullary MRI, lumbar puncture, CSF sampling; Biological: biological test

Study type: Interventional

Funder types: Other

Identifiers

NCT05286684

Exo-LCR

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Study process

Experimental group

Description:

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

Treatment:

Biological: biological test

Procedure: Cerebral and medullary MRI, lumbar puncture, CSF sampling

Procedure: Consultation