Pathogenicity of B and CD4 T Cell Subsets in 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: blood sample, cerebro-spinal fluid.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Clinically Isolated Syndrome. 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 →
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Overview
The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.
Detailed description
Multiple sclerosis (MS) is a chronic autoimmune disease damaging the central nervous system (CNS). MS is categorized into several distinct forms according to clinical symptoms and medical examinations. Relapsing-remitting multiple sclerosis (RRMS) is characterized by attacks of worsening neurologic function, followed by partial or complete recovery periods. Patients can also present a gradual but steady progression of the disease (progressive forms). While several treatment options are currently available, no treatment completely stops the disease progression. Therefore, a deeper understanding regarding the mechanism of the disease development is essential to generate more efficient treatment strategies. CD4 T cells are known to be significantly involved in the formation of the CNS lesions characteristic of MS.The investigators hypothesize that different types of B and CD4 T cells play major roles in different forms of the disease. They will determine the phenotype and functions of the cells from the immune system particularly B and CD4 T cells present in the blood and cerebro-spinal fluid (CSF) of patients diagnosed with multiple sclerosis or presenting a clinically isolated syndrome.
The study will recruit 150 patients followed in Bordeaux University Hospital and diagnosed for clinically isolated syndrome (CIS) or multiple sclerosis (MS). Blood and CSF will be collected during a scheduled visit to study the properties of cells from the immune system in particular CD4 T cells in multiple sclerosis. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with the properties of blood and CSF lymphocytes. No extra visit will be needed and the blood and CSF samples will be collected at the same times as those collected for clinical purposes.
Interventions
- Biological blood sample
28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation - Biological cerebro-spinal fluid
1 ml of cerebro-spinal fluid
Primary outcome measures
- Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients. [Time frame: At inclusion (day 0)]
Secondary outcome measures (11)
- Quantification of disease activity scores [Time frame: At inclusion (day 0)]
- Quantification of disease activity scores [Time frame: At inclusion (day 0)]
- Number of lesions [Time frame: At inclusion (day 0)]
- Size of lesions [Time frame: At inclusion (day 0)]
- Localisation of lesions [Time frame: At inclusion (day 0)]
- Types of lesions [Time frame: At inclusion (day 0)]
- duration of the disease [Time frame: At inclusion (day 0)]
- age at onset and progression [Time frame: At inclusion (day 0)]
- number of relapses [Time frame: At inclusion (day 0)]
- date of relapses [Time frame: At inclusion (day 0)]
- Treatment [Time frame: At inclusion (day 0)]
Eligibility criteria
Inclusion criteria
- male or female subjects ;
- Age ≥ 18 years;
- subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome;
- patients for which a blood draw and / or lumbar puncture to collect CSF is performed for diagnostic or therapeutic purpose;
- affiliated to an health insurance system;
- and who agree to participate in the study.
Exclusion criteria
- Pregnant or breastfeeding women,
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Bordeaux - service de neurologie — Bordeaux
Identifiers
NCT: NCT04798651 · CHUBX 2020/71