Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic

NCT05056740 | Unknown

• 1 other identifier: 21Neuro02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• 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).

  1 day

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.

  1 day

Study Arms (4)

MS

Patients with a definite MS diagnosis according to the 2017 McDonald criteria

Biological: Data analysis

Red-flag MS

Patients presenting with clinical, radiological or biological red flags for MS diagnosis who will be ultimately diagnosed as having MS

Biological: Data analysis

Other CNS autoimmune diseases

Patients with a definite diagnostic of CNS autoimmune disease that is not MS

Biological: Data analysis

Controls

Patients with a definite diagnostic of non-inflammatory CNS disorder

Biological: Data analysis

Interventions

Data analysis BIOLOGICAL

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

Controls; MS; Other CNS autoimmune diseases; Red-flag MS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred to our MS tertiary center for the diagnostic work-up of white matter hyperintensities suggestive of underlying inflammatory demyelinating disease

You may qualify if:

• 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

You may not qualify if:

• Patients with a contraindication to perform spinal tap (increase bleeding risk medicine or disease)
• Patients with a contraindication to MRI (metal prosthesis…)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nice

Nice, France

RECRUITING

MeSH Terms

Conditions

Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 24, 2021
• Study Start: June 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: November 1, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (1)