Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)

Study Overview
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Brief Summary
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The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.

Official Title
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Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Biomarkers analysis


Participation Criteria
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Eligibility Criteria
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Patients : Inclusion Criteria: Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory) At least 18 years of age Diagnosed with MS according to criteria 2017 at the time of their last visit. Non-opposition to participation in the study Having had at least one visit in the year following collection Follow-up for at least 1 year after collection. Having signed the OFSEP consent Exclusion Criteria: CIS patients with progressive MS Healthy volunteers : Inclusion Criteria: Age 18 years or older Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351). Matched on age and sex to patients of interest in the OFSEP cohort Not having objected to participation in the study Exclusion Criteria: Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MS CIS+<br> | Other: Biomarkers analysis<br>* Genetic analysis of regions of interest<br>|
| Healthy volunteers<br> | Other: Biomarkers analysis<br>* Genetic analysis of regions of interest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of immune subpopulations | Correlations between the frequency of immune subpopulations, genetic profile and disease activity | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of immune subpopulations correlated to EDSS score | Correlations between the frequency of immune subpopulations, genetic profile, and EDSS score ((Expanded Disability Status Scale, method of quantifying disability in multiple sclerosis, steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.) | 1 year | 
| Frequency of immune subpopulations correlated to disease progression delay | Correlations between the frequency of immune subpopulations, genetic profile, and delay before disease progression | 1 year | 
| Frequency of immune subpopulations correlated to disease progression events | Correlations between the frequency of immune subpopulations, genetic profile, and number of disease progression events | 1 year | 
| Frequency of immune subpopulations correlated to spinal lesions | Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions | 1 year | 
| Profiles of CIS+ patients | Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers | 1 year |