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NCT Number: NCT05056740

Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Nice

Nice, France

Location status: Recruiting

Location contact

Michael Levraut, MD

CONTACT

[email protected]

+33492034126

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Data analysis

Biological

Analysis of the data from routine care at the end of the diagnostic work-up

Primary outcomes

  1. Identify specific biomarkers profil in MS group

    Time frame: 1 day

    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).

Secondary outcomes

  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

    Proportion of CVS positive lesions in each group.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Evaluation of a Combined Analysis of Serum and Cerebrospinal Fluid Inflammatory Biomarkers to Help in Etiological Diagnosis of Central Nervous System Autoimmune Diseases

Acronym: CyBIRD

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Sep 24, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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