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TerminatedNCT01380041CYTOSEPUpdated Jul 21, 2015

Cytokine in Cerebrospinal Fluid (CSF) From Multiple Sclerosis Patients

An observational study in Multiple Sclerosis, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-21.

Sponsored by University Hospital, Montpellier · Observational

Why this study was terminated
Results obtained are sufficient for a publication.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
101
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple sclerosisCerebrospinal fluidBiomarkerCytokineArray
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 101 is close to the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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...

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
101 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

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.

    Time frame: 24 months

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Study locations

1 site
  • CHU Montpellier
    Montpellier, 34295, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01380041
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jun 27, 2011
Start date
Jun 2011
Primary completion
Jun 2011
Completion
Jun 2013
Last update
Jul 21, 2015

Study contacts

Eric THOUVENOT, MD-PhD
principal investigator · CHRU Montpellier

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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