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Cellular microRNA Signatures in Multiple Sclerosis (SEP-MIR)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
50 ml blodd sampling
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Inflammation, IFN-beta, Autoimmunity, Gene regulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hôpital La Pitié - Salpêtrière

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Untreated RRMS patients

Arm Description

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

Outcomes

Primary Outcome Measures

microRNA expression profiles in immune cell populations from RRMS patients
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
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
RNAseq and/or Nanostring sequencing of monocytes from RRMS patients

Full Information

First Posted
March 11, 2022
Last Updated
August 16, 2022
Sponsor
Institut Pasteur
Collaborators
Höpital La Pitié-Salpêtrière
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1. Study Identification

Unique Protocol Identification Number
NCT05290688
Brief Title
Cellular microRNA Signatures in Multiple Sclerosis
Acronym
SEP-MIR
Official Title
Cellular microRNA Signatures in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Höpital La Pitié-Salpêtrière

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Inflammation, IFN-beta, Autoimmunity, Gene regulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
20 untreated RRMS patients divided into 2 groups: 10 RRMS in relapsing phase 10 RRMS in relapse.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Untreated RRMS patients
Arm Type
Other
Arm Description
Untreated RRMS patients with a 50 ml blood sample during their routine care
Intervention Type
Genetic
Intervention Name(s)
50 ml blodd sampling
Intervention Description
50 ml blood sampling for genetic analysis (expression profiles of microRNAs)
Primary Outcome Measure Information:
Title
microRNA expression profiles in immune cell populations from RRMS patients
Description
RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients
Time Frame
2 years
Secondary Outcome Measure Information:
Title
microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
Description
RNAseq and/or Nanostring sequencing of unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
Time Frame
2 years
Title
microRNA expression profiles in monocytes from RRMS patients
Description
RNAseq and/or Nanostring sequencing of monocytes from RRMS patients
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédérique Michel, PhD
Phone
+33 1 45 68 86 38
Email
frederique.michel@pasteur.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédérique Michel, PhD
Organizational Affiliation
Institut Pasteur
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital La Pitié - Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Roux, MD
Phone
+33 1 42 16 17 51
Email
thomas.roux@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Cellular microRNA Signatures in Multiple Sclerosis

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