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Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05056740
Acronym
CyBIRD
Enrollment
300
Registered
2021-09-24
Start date
2020-06-01
Completion date
2025-11-01
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Diseases

Brief summary

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

BIOLOGICALData analysis

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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…)

Design outcomes

Primary

MeasureTime frameDescription
Identify specific biomarkers profil in MS group1 dayQuantification 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

MeasureTime frameDescription
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.1 dayProportion of CVS positive lesions in each group.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026