Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

NCT ID: NCT03974204

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2023-10-31

Brief Summary

This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.

Detailed Description

The aim of this study is to describe the association between the initial proteomic profile issued from cerebrospinal fluid microvesicles and the initial cytological analysis of the cerebrospinal fluid in breast cancer patients with a suspicion of metastatic meningitis.

Other objectives of the study include:

• Describing the association between the initial proteomic profile and:

• the histological types and hormonal receptors status of the breast cancer,
• the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification (Lack of evidence / possible / probable / confirmed) ,
• the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification, combined with histological type and hormonal receptors status.
• Evaluate the prognostic value of the proteomic profiling for overall survival, according to the EANO-ESMO classification and other known prognosis factors, in patients classified "possible", "probable" or "confirmed" leading to leptomeningeal metastases specific treatment,
• Evaluate the impact of the evolution of the proteomic profile a month after the start of this treatment on the overall survival, in patients with leptomeningeal metastases specific treatment,
• Evaluate the association between the proteomic profile and the EANO-ESMO classification at least 3 months after the initial EANO-ESMO classification,
• Evaluate the evolution of the proteomic profile 3 months after the initial EANO-ESMO classification, in patients initially classified "lack of evidence", broadly and according to the evolution of cytology, the administered treatments and to the EANO-ESMO response if applicable,
• Compare the proteomic profiles issued from cerebrospinal fluid and blood

Conditions

Breast Cancer; Leptomeningeal Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cerebrospinal fluid and Blood sample collection

Collection of cerebrospinal fluid and blood samples:

• At initial diagnostic assessment;
• 1 month and 3 months after initial diagnostic assessment, for patients classified "possible", "probable" or "confirmed" according to EANO-ESMO classification, leading to specific leptomeningeal metastase treatment;
• In case of symptoms leading to leptomeningeal metastase suspicion and at least 3 months after diagnostic assessment, for patients classified "lack of evidence" according to EANO-ESMO classification.

Group Type: EXPERIMENTAL

Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment

Intervention Type: PROCEDURE

At the initial diagnostic assessment, 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected in order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.

Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification

Intervention Type: PROCEDURE

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:

• When suspected metastatic meningitis symptoms arise and
• at least 3 months after the initial diagnostic assessment, In order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.

Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment

Intervention Type: PROCEDURE

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:

• 1 month after the beginning of the specific treatment,
• 3 months after the beginning of the specific treatment. Cerebrospinal fluid will be collected during a lumbar puncture aiming to assess treatment response or at intrathecal injection of treatment.

Interventions

Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment

At the initial diagnostic assessment, 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected in order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.

Intervention Type: PROCEDURE

Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:

• When suspected metastatic meningitis symptoms arise and
• at least 3 months after the initial diagnostic assessment, In order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.

Intervention Type: PROCEDURE

Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:

• 1 month after the beginning of the specific treatment,
• 3 months after the beginning of the specific treatment. Cerebrospinal fluid will be collected during a lumbar puncture aiming to assess treatment response or at intrathecal injection of treatment.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient with histologically proven breast cancer
• Patient with suspected metastatic leptomeningitis
• Age ≥ 18 years
• Patient covered by the French social security regime
• Signed written informed consent

Exclusion Criteria

• History of cancer other than the one being treated
• Contraindication to carrying out the lumbar puncture or cerebrospinal MRI
• Pregnant or breastfeeding patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie LE RHUN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Oscar Lambret

Locations

Centre Hospitalier Régional Universitaire de Lille

Lille, Hauts-de-France, France

Centre Oscar Lambret

Lille, Hauts-de-France, France

Countries

France

Other Identifiers

2018-A02358-47

Identifier Type: OTHER

Identifier Source: secondary_id

Exo-LCR

Identifier Type: -

Identifier Source: org_study_id