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From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis
NCT04873492 · Nantes University Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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
Study design
Enrollment target: 130 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-01-24
Estimated completion: 2029-07-24
Last updated: 2026-03-19
Interventions
Other: Biological sample collection
Primary outcomes
- • Bulk RNA-sequencing (Blood sample collection within 6 months after first inflammatory event for MS patients and at inclusion for healthy volunteers.)
Sponsor
Nantes University Hospital · other
Contacts & investigators
ContactDavid LAPLAUD, PhD · contact · david.laplaud@chu-nantes.fr · 33 2 40 16 52 00
All locations (1)
Nantes University HospitalRecruiting
Nantes, Loire-Atlantique, France