Cytokine in Cerebrospinal Fluid (CSF) From Multiple Sclerosis Patients (CYTOSEP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01380041
First received: June 17, 2011
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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).


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Multiple Sclerosis Biomarkers in Human CSF by Means of Cytokine Array

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
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)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380041

Contacts
Contact: Thouvenot Eric, MD, PhD +33 (0)4 66 68 32 61

Locations
France
CHU Montpellier Recruiting
Montpellier, France, 34295
Contact: Thouvenot Eric, Md, PhD    +33 (0)4 66 68 32 61    ethouvenot@hotmail.com   
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01380041     History of Changes
Other Study ID Numbers: 8669, 2010-AO1321-38
Study First Received: June 17, 2011
Last Updated: June 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
Multiple sclerosisCerebrospinal fluidBiomarkerCytokineArray

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014