Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data analysis.
- Who it may be relevant to
- Registry conditions: Central Nervous System Diseases. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Combined Analysis of Serum and Cerebrospinal Fluid Inflammatory Biomarkers to Help in Etiological Diagnosis of Central Nervous System Autoimmune Diseases
Overview
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.
Interventions
- Biological Data analysis
Analysis of the data from routine care at the end of the diagnostic work-up
Primary outcome measures
- Identify specific biomarkers profil in MS group [Time frame: 1 day]
Secondary outcome measures (1)
- 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. [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- Patients referred to our center for the diagnostic work-up of White Matter Lesions
- Patients that need a routine blood analysis
- Patients that need a routine CSF analysis
- Non opposition to research consent
Exclusion criteria
- Patients with a contraindication to perform spinal tap (increase bleeding risk medicine or disease)
- Patients with a contraindication to MRI (metal prosthesis…)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre Hospitalier Universitaire de Nice — Nice
Identifiers
NCT: NCT05056740 · 21Neuro02