Cellular microRNA Signatures in Multiple Sclerosis (SEP-MIR)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Frédérique Michel, PhD
- Telefonnummer: +33 1 45 68 86 38
- E-mail: frederique.michel@pasteur.fr
Studiesteder
-
-
-
Paris, Frankrig, 75013
- Hôpital La Pitié - Salpêtrière
-
Kontakt:
- Thomas Roux, MD
- Telefonnummer: +33 1 42 16 17 51
- E-mail: thomas.roux@aphp.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Untreated RRMS patients
Untreated RRMS patients with a 50 ml blood sample during their routine care
|
50 ml blood sampling for genetic analysis (expression profiles of microRNAs)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
microRNA expression profiles in immune cell populations from RRMS patients
Tidsramme: 2 years
|
RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients
Tidsramme: 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
Tidsramme: 2 years
|
RNAseq and/or Nanostring sequencing of monocytes from RRMS patients
|
2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Frédérique Michel, PhD, Institut Pasteur
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021-044
- 2021-A02983-3 (Anden identifikator: ID-RCB)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .