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Spots Global Cancer Trial Database for Study in Leptomeningeal Metastases of Breast Cancer

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Trial Identification

Brief Title: Study in Leptomeningeal Metastases of Breast Cancer

Official Title: Cerebrospinal Fluid Biomarkers Value: Exploratory and Prospective Study in Leptomeningeal Metastases of Breast Cancer (LCS Bio Sein)

Study ID: NCT03252912

Conditions

Breast Cancer

Interventions

blood samples

Study Description

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

Detailed Description: 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. Other CSF biomarkers have been evaluated for the diagnosis of leptomeningeal metastases. Finally, the CellSearch® technique allows for the characterisation of proteins expressed by CSF tumors cells (E.G., HER2) and will make possible a better understanding of the physiopathology of tumor dissemination to the CS. Other neuronal biomarkers could be interesting for the diagnosis of LM in BC patients. Among them, the protein Tau (total-Tau or T-Tau) is involved in several neurological diseases. However, to date, no study has evaluated CSF or serum T-Tau in LM from solid tumors. 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Institut régional du Cancer de Montpellier, Montpellier, , France

Contact Details

Name: marc ychou

Affiliation: institut régional du Cancer de Montpellier

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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