Study in Leptomeningeal Metastases of Breast Cancer

NCT03252912 | Completed

• 1 other identifier: ICM-URC 2015/71
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer (BC) is the most frequent cause of leptomeningeal metastases (LM) .As for brain parenchymal metastases, the incidence of LM seems to be increasing, due to the growing incidence of metastatic BC, the improvement of survival and the poor diffusion of therapeutic agents into the central nervous system (CNS). Several prognostic factors have been identified, including the age at diagnosis, the functional and neurological status, the delay between the diagnosis of cancer and that of LM. The survival of patients is poor, less than 6 months in most published series. Several neuronal biomarkers could also be good candidates, such as the neurogranin CSF and/or serum levels or the CNS neurofilaments (NF), that seem to be a good reflect of axonal injury and neuronal loss. CNS NF have been investigated in several neurological diseases including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and multiple sclerosis, but not yet in CNS metastases. Indeed, the creation of a clinico-biological collection seems to be of high value in order to investigate future biomarkers of interest

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the CellSearch® technique on CSF samples in comparison with the conventional cytology on one to three CSF sample

  analysis of result with the 2 technical procedure

  through study completion, an average of 2 years

Study Arms (1)

Biological samples

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.

Biological: blood samples

Interventions

blood samples BIOLOGICAL

Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar .

Biological samples

Eligibility Criteria

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

You may qualify if:

• Male or female patient ≥ 18 years-old, no age limit;
• Histologically confirmed diagnosis of BC;
• Hormone receptors and HER2 statuses of the primary tumor available;
• Suspected LM based on clinical symptoms or signs, or radiological abnormalities;
• Indication of diagnosis lumbar puncture decided by the oncologist in charge of the patient;
• Patients must be affiliated to a Social Security System;
• Patient information and written informed consent form signed prior to any study specific procedures.

You may not qualify if:

• History of other cancer(s) than the BC (except completely resected non-melanoma skin cancer or successfully treated in situ carcinoma).
• Hormone receptors and/or HER2 statuses of the primary tumor not available;
• Patients with a medical contra-indication to the realization of a lumbar puncture;
• Patients with psychological, family, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
• Patients who are pregnant or breast-feeding.
• Legal incapacity or limited legal capacity.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (2)

• Darlix A, Cayrefourcq L, Pouderoux S, Menjot de Champfleur N, Bievelez A, Jacot W, Leaha C, Thezenas S, Alix-Panabieres C. Detection of Circulating Tumor Cells in Cerebrospinal Fluid of Patients with Suspected Breast Cancer Leptomeningeal Metastases: A Prospective Study. Clin Chem. 2022 Oct 6;68(10):1311-1322. doi: 10.1093/clinchem/hvac127.

  PMID: 35953885 BACKGROUND

• Delaby C, Al Herk A, Hirtz C, Jacot W, Laigre M, Pouderoux S, Pradeilles N, Lehmann S, Darlix A. Hepcidin as an emerging predictor biomarker of leptomeningeal metastases in patients with metastatic breast cancer. BMC Cancer. 2025 Nov 21;25(1):1801. doi: 10.1186/s12885-025-15124-6.

  PMID: 41272605 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• marc ychou

  institut régional du Cancer de Montpellier

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 17, 2017
• Study Start: January 6, 2017
• Primary Completion: February 3, 2020
• Study Completion: September 15, 2020
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

FR (1)