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

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Biological sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04873492

RC20_0404

Details and patient eligibility

About

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

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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
• Adults under a legal protection regime (guardianship, trusteeship, judicial safeguard)
• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 4 patient groups

Retrospective Aggressive MS patients

Other group

Description:

Patients from who the clinical outcome is already known and classified as poor based on study definition detailed in inclusion criteria (retrospective arm). Blood sample collected after first event is available and used to characterize OMIC profile of T and B cells involve in MS.

Treatment:

Other: Biological sample collection

Retrospective Non Aggressive MS patient

Other group

Description:

Patient from who the clinical outcome is already known and classified as non-aggressive based on study definition detailed in inclusion criteria (retrospective arm). Blood sample collected after first event is available and used to characterize OMIC profile of T and B cells involve in MS.

Treatment:

Other: Biological sample collection

Healthy volunteers

Other group

Description:

Prospective arm use as comparator.

Treatment:

Other: Biological sample collection

Prospective MS patients

Other group

Description:

MS patients from who the clinical outcome will be established at the end of the follow up. Blood sample will be collected after the first event to validate molecules of interest from OMIC results by using FACS a different technology and classify MS patient.

Treatment:

Other: Biological sample collection