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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Consultation
Cerebral and medullary MRI, lumbar puncture, CSF sampling
biological test
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring leptomeningeal metastases, proteomic profile, cerebrospinal fluid, cytology analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Centre Oscar LambretRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study process

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2022
Last Updated
February 7, 2023
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT05286684
Brief Title
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)
Acronym
Exo-LCR
Official Title
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis From Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
leptomeningeal metastases, proteomic profile, cerebrospinal fluid, cytology analysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study process
Arm Type
Experimental
Arm Description
Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid
Intervention Type
Procedure
Intervention Name(s)
Consultation
Intervention Description
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
Intervention Name(s)
Cerebral and medullary MRI, lumbar puncture, CSF sampling
Intervention Description
diagnosis of leptomeningeal involvement
Intervention Type
Biological
Intervention Name(s)
biological test
Intervention Description
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 Outcome Measure Information:
Title
CSF protein composition
Description
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.
Time Frame
36 months
Title
cytological analysis of the CSF
Description
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.
Time Frame
36 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Thery
Phone
+33320295918
Email
promotion@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Cheymol, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
State/Province
Hauts De France
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire CHEYMOL
Phone
+33 20 29 59 43
Email
c-cheymol@o-lambret.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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