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Recruiting NCT04873492

From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis

No phase Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological sample collection.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

MS is a heterogeneous disease either in its response to treatment or clinical manifestation. Indeed, the natural history of MS is varying from a benign condition to a devastating and rapidly incapacitating disease. Clinical heterogeneity could also be cellular and / or molecular. The aim is to identify from OMIC analyses, at the early stage of the disease, differentially expressed molecules and / or cell subpopulations derived from CD8 + T lymphocytes and / or CD4 + T lymphocytes and / or B lymphocytes and monocytes from patients with aggressive versus non-aggressive, compared to a cohort of healthy controls

Interventions

  • Other Biological sample collection
    Venous blood sample will be collected from patients belonging to validation cohort and healthy volunteers at baseline resulting in 90 Ml EDTA tube and 10 ml serum tube. Approximately 100 ml will be collected. optional saliva and stool collection will be performed.

Primary outcome measures

  • Bulk RNA-sequencing [Time frame: Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.]
Secondary outcome measures (4)
  • Single RNA sequencing [Time frame: Blood sample collection within 6 months after first inflammatory event.]
  • Association of genetic sequence variation from whole genome sequencing with gene expression profile via Bulk RNA-seq [Time frame: Blood sample collection within 6 months after first inflammatory event.]
  • Association of transcriptomic variation with DNA methylation [Time frame: Blood sample collection within 6 months after first inflammatory event.]
  • OMIC integration [Time frame: Blood sample collection within 6 months after first inflammatory event.]

Eligibility criteria

Inclusion criteria

Common criteria for retrospective MS patients:

  • Patients aged 18 years or older
  • Clinical isolated syndrome (CIS) with or without dissemination in space
  • Patients affiliated to an appropriate health insurance

Criteria for Aggressive MS group

  • Start of a 2nd line therapy within the two years following the CIS

Criteria for Non aggressive MS group

  • No conversion according to McDonald criteria from clinical isolated syndrome to multiple sclerosis within 2 years or
  • Conversion based to McDonald criteria treated or not with first line disease modifying therapy within 2 years.
  • Have a minimum of least 2 years of follow-up.

Healthy volunteers

  • Aged 18 years or older
  • No history of clinically isolated syndrome or MS

Pairing criteria :

  • Age +/- 5 years
  • Sex

Prospective MS Patients

  • Patients aged 18 years or older
  • Clinical isolated syndrome (CIS) with or without dissemination in space
  • Patients affiliated to an appropriate health insurance

Exclusion criteria

  • Ongoing participation to a another study
  • Refusal to genetic analyses
  • Immunosuppressive drug at the time of blood collection
  • Plasma exchange or corticosteroid treatment within the four weeks prior to blood sample
  • Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Nantes University Hospital — Nantes

Identifiers

NCT: NCT04873492 · RC20_0404

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗