An observational study in Central Nervous System Diseases, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
Project rationale:
Since 2017, multiple sclerosis diagnosis should match the new McDonald criteria in which a "no better explanation than MS" should be fulfilled. However, many patients present with red flags that lead to a complex diagnostic work-up. There are no available biomarkers that permit to confirm or roll out MS diagnosis in such cases. Therefore, we lack biological markers that can help in the diagnosis of patients presenting with suspected MS.
Many studies have found that serum and cerebrospinal fluid (CSF) cytokines could help to differentiate MS from other diseases such as neuromyelitis optica spectrum disorders (i.e., IL-6) or neurosarcoidosis (i.e., sIL-2R). Serum and CSF kappa free light chains have also shown good diagnosis performance in MS. In daily practice, our MS tertiary center already perform the analysis of CSF concentrations of IL-1β, sIL-2R, IL-6, IL-10, and serum and CSF kappa and lambda free light chains to roll out other central nervous system (CNS) autoimmune diseases in patients presenting with white matter hyperintensities (WMH).
Objective:
To correlate CSF IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains with the final diagnosis in patients presenting to our MS tertiary center with suspected MS to identify a specific inflammatory biomarker profil involved in MS and other CNS autoimmune diseases.
The methodology:
This is an observational study. All patients ongoing a routine diagnostic work-up for suspected MS from june 2020 to june 2022 in our MS tertiary center will be analyzed. Cerebrospinal fluid IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains will be correlated with the final diagnosis to ultimately find MS associated biomarkers.
253 studies on the registry are indexed under Central Nervous System Diseases; 91 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 58 observational studies indexed under Central Nervous System Diseases.
Browse Central Nervous System Diseases studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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All patients referred to our MS tertiary center for the diagnostic work-up of white matter hyperintensities suggestive of underlying inflammatory demyelinating disease
Exclusion Criteria:
Patients with a definite MS diagnosis according to the 2017 McDonald criteria
Biological: Data analysis
Patients presenting with clinical, radiological or biological red flags for MS diagnosis who will be ultimately diagnosed as having MS
Biological: Data analysis
Patients with a definite diagnostic of CNS autoimmune disease that is not MS
Biological: Data analysis
Patients with a definite diagnostic of non-inflammatory CNS disorder
Biological: Data analysis
Analysis of the data from routine care at the end of the diagnostic work-up
Identify specific biomarkers profil in MS group
Quantification in each group of patients of IL-1beta, soluble receptor of IL-2, IL-6 and IL-10 by ELISA and cerebrospinal fluid/serum kappa and lambda free light chains by using the turbidimetric analyzer Optilite (BindingSite).
Time frame: 1 day
To define the diagnosis performance of "Central vein sign (CVS)" in Radiologically Isolated Syndrome subjects compared to MS patients and patients with WM abnormalities of another origin.
Proportion of CVS positive lesions in each group.
Time frame: 1 day
Plan to share: Undecided
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Central Nervous System Diseases→
Centre Hospitalier Universitaire de Nice