Cellular microRNA Signatures in Multiple Sclerosis

NCT ID: NCT05290688

Last Updated: 2022-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2024-09-15

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.

Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Untreated RRMS patients

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

Group Type OTHER

50 ml blodd sampling

Intervention Type GENETIC

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

Interventions

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50 ml blodd sampling

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

Intervention Type GENETIC

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Höpital La Pitié-Salpêtrière

UNKNOWN

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédérique Michel, PhD

Role: STUDY_DIRECTOR

Institut Pasteur

Locations

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Hôpital La Pitié - Salpêtrière

Paris, , France

Site Status

Countries

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France

Central Contacts

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Frédérique Michel, PhD

Role: CONTACT

+33 1 45 68 86 38

Facility Contacts

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Thomas Roux, MD

Role: primary

+33 1 42 16 17 51

Other Identifiers

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2021-A02983-3

Identifier Type: OTHER

Identifier Source: secondary_id

2021-044

Identifier Type: -

Identifier Source: org_study_id

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