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NCT Number: NCT05286684

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Central Nervous System Neoplasms Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, Hauts-de-France, 59000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultation

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

Procedure

diagnosis of leptomeningeal involvement

Biological Test

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

Primary outcomes

  1. CSF protein composition

    Time frame: 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.

  2. cytological analysis of the CSF

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: Exo-LCR

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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