SEP-MIR: Cellular microRNA Signatures in Multiple Sclerosis

Sponsor

Institut Pasteur (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05290688

Collaborator

Höpital La Pitié-Salpêtrière (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Genetic: 50 ml blodd sampling	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

20 untreated RRMS patients divided into 2 groups: 10 RRMS in relapsing phase 10 RRMS in relapse.20 untreated RRMS patients divided into 2 groups: 10 RRMS in relapsing phase 10 RRMS in relapse.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Cellular microRNA Signatures in Multiple Sclerosis

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Sep 15, 2024

Anticipated Study Completion Date :

Sep 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Untreated RRMS patients Untreated RRMS patients with a 50 ml blood sample during their routine care	Genetic: 50 ml blodd sampling 50 ml blood sampling for genetic analysis (expression profiles of microRNAs)

Arm

Intervention/Treatment

Other: Untreated RRMS patients

Untreated RRMS patients with a 50 ml blood sample during their routine care

Genetic: 50 ml blodd sampling

50 ml blood sampling for genetic analysis (expression profiles of microRNAs)

Outcome Measures

Primary Outcome Measures

microRNA expression profiles in immune cell populations from RRMS patients [2 years]
RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients

Secondary Outcome Measures

microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients [2 years]
RNAseq and/or Nanostring sequencing of unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
microRNA expression profiles in monocytes from RRMS patients [2 years]
RNAseq and/or Nanostring sequencing of monocytes from RRMS patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.