Cytokine in Cerebrospinal Fluid (CSF) From Multiple Sclerosis Patients (CYTOSEP)
Recruitment status was Recruiting
Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies are also expected to improve MS care. Cytokine arrays provide measure of many different inflammation-related molecules that could help understanding the disease. Moreover, individual prognosis could be linked with the level of such molecules in the CSF of MS patients. The investigators will analyze the cytokine profile of MS and control patients CSF to determine a specific profile of MS and look for prognosis implication in a cohort of patients with clinically isolated syndromes (first manifesatation of MS).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Identification of Multiple Sclerosis Biomarkers in Human CSF by Means of Cytokine Array|
- Identification of SEP markers [ Time Frame: 24 months ] [ Designated as safety issue: No ]The aim of this study is to measure the level of 40 cytokines and 10 MMPs by means of protein arrays in the CSF from clinically definite MS (CDMS) patients, control patients and patients with a clinically isolated syndrome (CIS). The best MS markers will be determined using multiple ROC curves.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Early treatment could allow better prognosis for the patients in the long term by reducing relapses rates and neurological palsy. However, individual prognostic biomarkers are still needed to adapt the treatment to a given patient. CSF is a strategic body fluid to explore in neurological diseases. In MS, it contains an elevated IgG index and/or oligoclonal bands reflecting the intrathecal synthesis of Igs around the brain. The levels of other inflammatory molecules such cytokines and metalloproteases are also known to be elevated in MS (GM-CSF, IL-6, IL-10, MMP-2, MMP9, TIMP-1, TNF-α, RANTES, MCP-1 and MIP-1). These molecules can now be easily measured by protein arrays.The aim of this study is to measure the level of 40 cytokines and 10 MMPs by means of protein arrays in the CSF from clinically definite MS (CDMS) patients, control patients and patients with a clinically isolated syndrome (CIS). The best MS markers will be determined using multiple ROC curves. Markers of rapid conversion to CDMS after a CIS will also be looked for.The best MS candidate biomarkers will be analyzed by ELISA in a new cohort of patients being recruited.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380041
|Contact: Thouvenot Eric, MD, PhD||+33 (0)4 66 68 32 61|
|Montpellier, France, 34295|
|Contact: Thouvenot Eric, Md, PhD +33 (0)4 66 68 32 61 firstname.lastname@example.org|