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

NCT03974204 | Withdrawn

• 2 other identifiers: Exo-LCR2018-A02358-47
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Leptomeningeal Metastasis

Keywords

Cerebrospinal fluid; Proteomic profile

Outcome Measures

Primary Outcomes (2)

• Proteomic profiles issued from cerebrospinal fluid at diagnosis

  Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.

  Up to 1 week

• Cytology of cerebrospinal fluid at diagnosis

  Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".

  Up to 1 week

Secondary Outcomes (6)

• Proteomic profiles issued from cerebrospinal fluid

  Up to 3 months

• Histological subtype

  Before registration in study

• Hormonal receptors status

  Before registration in study

• Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.

  Up to 3 months after the intial diagnosis

• Overall survival

  Time from date of registration to date of death regardless of the cause, assessed up to 1 year

Study Arms (1)

Cerebrospinal fluid and Blood sample collection

EXPERIMENTAL

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.

Procedure: Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment; Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification; Procedure: Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment

Interventions

Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment 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

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

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

Cerebrospinal fluid and Blood sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (2)

Centre Hospitalier Régional Universitaire de Lille

Lille, Hauts-de-France, 59000, France

Location

Centre Oscar Lambret

Lille, Hauts-de-France, 59020, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Meningeal Carcinomatosis

Interventions

Probability

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emilie LE RHUN, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: July 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: September 26, 2025

Record last verified: 2021-10

Locations

FR (2)