Completed

LCS Bio SeinExploration of Cerebrospinal Fluid Biomarkers' Value in Breast Cancer Leptomeningeal Metastases

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Study Aim

This study aims to compare the sensitivity of the CellSearch® technique and conventional cytology on cerebrospinal fluid samples in detecting breast cancer leptomeningeal metastases.

What is being tested

blood samples

Biological
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2017
See protocol details

Summary

Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 6, 2017

Actual date on which the first participant was enrolled.

Breast cancer often leads to a condition called leptomeningeal metastases (LM), where the cancer spreads to the fluid and membranes around the brain and spinal cord. This study focuses on understanding LM better, as its incidence seems to be rising due to improved survival rates and limitations in treating the central nervous system. The study aims to identify various biomarkers, or substances that indicate the presence of cancer, in the cerebrospinal fluid (CSF). One such biomarker is a protein called Tau, which is involved in several neurological diseases but hasn't been studied in LM from solid tumors like breast cancer. The study also uses a technique called CellSearch® to characterize proteins expressed by tumor cells in the CSF, which could improve understanding of how cancer spreads to the central nervous system. Participants in this study will provide one to three samples of cerebrospinal fluid. These samples will be analyzed using both the conventional cytology method and the CellSearch® technique. The main goal is to compare the sensitivity of these two methods in detecting cancer cells in the fluid. The study will also examine other potential biomarkers, such as neurogranin and neurofilaments, which could reflect axonal injury and neuronal loss.

Official TitleCerebrospinal Fluid Biomarkers Value: Exploratory and Prospective Study in Leptomeningeal Metastases of Breast Cancer (LCS Bio Sein)
NCT03252912
Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

7 inclusion criteria required to participate
Histologically confirmed diagnosis of BC
Patient information and written informed consent form signed prior to any study specific procedures
Patients must be affiliated to a Social Security System
Indication of diagnosis lumbar puncture decided by the oncologist in charge of the patient
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6 exclusion criteria prevent from participating
Patients with a medical contra-indication to the realization of a lumbar puncture
Patients who are pregnant or breast-feeding
Patients with psychological, family, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Legal incapacity or limited legal capacity
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The CSF samples will be taken at the occasion of the first lumbar puncture performed for clinical purposes (suspected LM). If necessary for the routine diagnosis, a second and a third lumbar puncture will be performed according to the gold standard Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar puncture and transferred at ambient temperature to the Biological Resource Center of the ICM (Jean-Pierre Bleuse, Biobank number BB-0033-00059) to be processed within 1 hour Blood samples will be centrifuged at 3,000 g for 10 minutes at ambient temperature and will be aliquoted in 4 plasma and 4 serum aliquots and then stored at -80°C. Aliquots must be anonymized.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Institut régional du Cancer de Montpellier

Montpellier, FranceOpen Institut régional du Cancer de Montpellier in Google Maps
CompletedOne Study Center
LCS Bio Sein | Exploration of Cerebrospinal Fluid Biomarkers' Value in Breast Cancer Leptomeningeal Metastases | PatLynk