Cellular microRNA Signatures in Multiple Sclerosis

Study Overview
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Brief Summary
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A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC). In a number of cases, RRMS progresses to a severe secondary neurodegenerative form. In this context, it is important to look for biomarkers that could indicate the pathogenic activity of certain immune cell subpopulations.

Detailed Description
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SEP-MIR is a prospective, single-center, descriptive study. Participants will be recruited among adult patients with RRMS coming for a follow-up consultation in the Neurology Department, Nervous System Diseases Pole, at the hôpital Pitié - Salpêtrière (Paris). As this is a descriptive study, the recruitment of 20 participants (10 patients with relapsing-remitting MS and 10 patients with relapsing-remitting MS) should meet the objectives of this study. A 50 ml blood sample will be obtained from each participant and several clinical data regarding their pathology will be collected.

Official Title
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Cellular microRNA Signatures in Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Genetic: 50 ml blodd sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian population Female and male individuals with an f/m ratio of 2-4/1 Individuals with RRMS according to the 2010 McDonald criteria for less than 15 years, with EDSS 1-6, in remission or relapse Participant's condition compatible with a maximum of 50 ml of blood collection Persons affiliated with a social security plan. Exclusion Criteria: MS treatment with steroidal anti-inflammatory drugs, immunomodulators or immunosuppressants within 2 months prior to blood collection Persons with acute and chronic infectious disease, autoimmune/inflammatory disease or cancer other than MS Pregnant or lactating women Be under guardianship, Be deprived of liberty by judicial or administrative decision, or be under legal protection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: 20 untreated RRMS patients divided into 2 groups: 10 RRMS in relapsing phase 10 RRMS in relapse.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Untreated RRMS patients<br>Untreated RRMS patients with a 50 ml blood sample during their routine care | Genetic: 50 ml blodd sampling<br>* 50 ml blood sampling for genetic analysis (expression profiles of microRNAs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microRNA expression profiles in immune cell populations from RRMS patients | RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients | RNAseq and/or Nanostring sequencing of unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients | 2 years | 
| microRNA expression profiles in monocytes from RRMS patients | RNAseq and/or Nanostring sequencing of monocytes from RRMS patients | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, IFN-beta, Autoimmunity, Gene regulation