Cellular microRNA Signatures in Multiple Sclerosis

NCT05290688 | Unknown

• 2 other identifiers: 2021-0442021-A02983-3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Inflammation; IFN-beta; Autoimmunity; Gene regulation

Outcome Measures

Primary Outcomes (1)

• microRNA expression profiles in immune cell populations from RRMS patients

  RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients

  2 years

Secondary Outcomes (2)

• microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients

  2 years

• microRNA expression profiles in monocytes from RRMS patients

  2 years

Study Arms (1)

Untreated RRMS patients

OTHER

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

Genetic: 50 ml blodd sampling

Interventions

50 ml blodd sampling GENETIC

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

Untreated RRMS patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Pasteur: lead
• Höpital La Pitié-Salpêtrière: collaborator

Study Sites (1)

Hôpital La Pitié - Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Inflammation; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frédérique Michel, PhD

  Institut Pasteur

  STUDY DIRECTOR

Central Study Contacts

Frédérique Michel, PhD

CONTACT

+33 1 45 68 86 38; frederique.michel@pasteur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: September 15, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

FR (1)