Cellular microRNA Signatures in Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Genetic: 50 ml blodd sampling

• Registration Number: NCT05290688
• Lead Sponsor: Institut Pasteur

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.

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 Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17
• Study Start: 2022-09-15
• Primary Completion: 2024-09-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Untreated RRMS patients	50 ml blodd sampling	Untreated RRMS patients with a 50 ml blood sample during their routine care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital La Pitié - Salpêtrière; 🇫🇷 Paris, France