Cytokine in Cerebrospinal Fluid (CSF) From Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— CYTOSEP  

Official title:

Identification of Multiple Sclerosis Biomarkers in Human CSF by Means of Cytokine Array

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01380041
• Other study ID #: 8669
• Secondary ID: 2010-AO1321-38
• Status: Terminated
• Phase: N/A
• First received: June 17, 2011
• Last updated: July 20, 2015
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2011
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: June 2013
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically definite Multiple sclerosis patients (at least 2 relapses)

• Patient having presented another neurological episode suggestive of MULTIPLE SCLEROSIS confirmed or not by a neurologist and allowing to establish the diagnosis of MULTIPLE SCLEROSIS according to the criteria of Mc Donald

• Age = 18 years

• Patients informed about the objectives of the study and about its practical realization

Exclusion Criteria:

• Patient having received a treatment by corticoids in 30 days before the lumbar puncture

• Contraindication of the lumbar puncture such as an anticoagulating oral treatment for example

• Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of SEP markers	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.	24 months	No