Cytokine in Cerebrospinal Fluid (CSF) From Multiple Sclerosis Patients

NCT01380041 | Terminated

• 2 other identifiers: 86692010-AO1321-38
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosisCerebrospinal fluidBiomarkerCytokineArray

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Clinically definite Multiple sclerosis patients (at least 2 relapses)Control patients (lumbar puncture for headache…

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric THOUVENOT, MD-PhD

  CHRU Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2013
• Last Updated: July 21, 2015

Record last verified: 2011-06

Locations

FR (1)