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

October 5, 2021 updated by: Centre Oscar Lambret

Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

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.

Study Overview

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

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hauts-de- France
      • Lille, Hauts-de- France, France, 59020
        • Centre Oscar Lambret
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59000
        • Centre Hospitalier Regional Universitaire de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomic profiles issued from cerebrospinal fluid at diagnosis
Time Frame: Up to 1 week
Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.
Up to 1 week
Cytology of cerebrospinal fluid at diagnosis
Time Frame: Up to 1 week
Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".
Up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomic profiles issued from cerebrospinal fluid
Time Frame: Up to 3 months

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

  • 1 month and 3 month after the start of a specific treatment of the leptomeningeal metastasis, if applicable,
  • 3 months after the initial diagnosis of leptomeningeal metastasis if the likehood of leptomeningeal metastasis is "lack of evidence".
Up to 3 months
Histological subtype
Time Frame: Before registration in study
Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.
Before registration in study
Hormonal receptors status
Time Frame: Before registration in study

Hormonal receptors status will be subdivised as:

  • Positive hormonal receptors / Positive HER2
  • Positive hormonal receptors / Negative HER2
  • Negative hormonal receptors / Positive HER2
  • Triple negative
Before registration in study
Likehood of leptomeningeal metastasis according to the EANO-ESMO classification.
Time Frame: Up to 3 months after the intial diagnosis

EANO-ESMO classification is obtained by searching clinical symptoms, cancer cells in the cerebrospinal fluid (obtained by lumbar puncture), signs in RMI. The likehood of leptomeningeal metastasis is:

  • Lack of evidence,
  • Possible,
  • Probable,
  • Confirmed.
Up to 3 months after the intial diagnosis
Overall survival
Time Frame: Time from date of registration to date of death regardless of the cause, assessed up to 1 year
Overall survival is defined as time from date of registration to date of death regardless of the cause.
Time from date of registration to date of death regardless of the cause, assessed up to 1 year
Proteomic profiles issued from blood
Time Frame: Up to 3 months after the intial diagnosis
Proteomic profile will be obtained by bioinformatic analysis of blood.
Up to 3 months after the intial diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emilie Le Rhun, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment

Subscribe