Cellular microRNA Signatures in Multiple Sclerosis (SEP-MIR)

August 16, 2022 updated by: Institut Pasteur

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Hôpital La Pitié - Salpêtrière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

Höpital La Pitié-Salpêtrière

Investigators

  • Study Director: Frédérique Michel, PhD, Institut Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2022

Primary Completion (Anticipated)

September 15, 2024

Study Completion (Anticipated)

September 15, 2024

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-044
  • 2021-A02983-3 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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