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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Consultation; Procedure: Cerebral and medullary MRI, lumbar puncture, CSF sampling; Biological: biological test

• Registration Number: NCT05286684
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-18
• Study Start: 2023-01-04
• Primary Completion: 2023-11-15
• Study Completion: 2023-11-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study process	Cerebral and medullary MRI, lumbar puncture, CSF sampling	Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid
Study process	biological test	Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid
Study process	Consultation	Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid

Primary Outcome Measures

Name	Time	Method
cytological analysis of the CSF	36 months	The cytological analysis of the CSF will allow to obtain 3 possible results: Positive / Negative / Equivocal at the time of the initial diagnostic workup for all patients and in case of renewal of the initial LP if the 1st one was not exploitable for the cytological analysis of the CSF, for all patients.
CSF protein composition	36 months	The CSF proteomic profile will be obtained by an unsupervised bioinformatics analysis of the CSF collected during the initial diagnostic workup for all patients and in case of renewal of the initial lumbar puncture if the 1st one was not exploitable for the CSF cytological analysis.; The bioinformatics analysis will allow to obtain the protein composition and to establish proteomic profile.

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, Hauts de France, France