Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic
NCT ID: NCT05056740
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2020-06-01
2025-11-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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MS
Patients with a definite MS diagnosis according to the 2017 McDonald criteria
Data analysis
Analysis of the data from routine care at the end of the diagnostic work-up
Red-flag MS
Patients presenting with clinical, radiological or biological red flags for MS diagnosis who will be ultimately diagnosed as having MS
Data analysis
Analysis of the data from routine care at the end of the diagnostic work-up
Other CNS autoimmune diseases
Patients with a definite diagnostic of CNS autoimmune disease that is not MS
Data analysis
Analysis of the data from routine care at the end of the diagnostic work-up
Controls
Patients with a definite diagnostic of non-inflammatory CNS disorder
Data analysis
Analysis of the data from routine care at the end of the diagnostic work-up
Interventions
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Data analysis
Analysis of the data from routine care at the end of the diagnostic work-up
Eligibility Criteria
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Inclusion Criteria
* 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 MRI (metal prosthesis…)
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Centre Hospitalier Universitaire de Nice
Nice, , France
Countries
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Facility Contacts
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Other Identifiers
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21Neuro02
Identifier Type: -
Identifier Source: org_study_id
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