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

Breast Cancer Clinical Trial

— Exo-LCR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286684
• Other study ID #: Exo-LCR
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Centre Oscar Lambret
• Contact: Julien Thery
• Phone: +33320295918
• Email: promotion[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Meningitis

Intervention

Procedure:
• 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.
• Cerebral and medullary MRI, lumbar puncture, CSF sampling
diagnosis of leptomeningeal involvement

Biological:
• 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

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille	Hauts De France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF protein composition	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.	36 months
Primary	cytological analysis of the CSF	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.	36 months