Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion

Study Overview
=================
Brief Summary
-----------------
This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.

Official Title
-----------------
Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)

Conditions
-----------------
Clinically Isolated Syndrome, Multiple Sclerosis

Intervention / Treatment
-----------------
* Procedure: tears and cerebrospinal fluid sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or more Clinically isolated syndrome of less than 3 months of onset Informed consent to participate Exclusion Criteria: Progressive primary multiple sclerosis Relapsing remitting multiple sclerosis Persons wearing contact lenses Ocular Infection Corticoid treatment at least 30 days before sampling Immunosuppressive or immunomodulatory treatment at least 3 months before sampling Pregnancy or breast feeding No coverage by the Social Insurance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tears and cerebro-spinal fluid sampling<br> | Procedure: tears and cerebrospinal fluid sampling<br>* All patients recruited in this study will undergo a cerebrospinal fluid sampling which is an invasive procedure included in the actual routine practice. In addition a sampling from eyes will be obtain using the Schirmer test to get tears from the lacrimal gland.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between the quantification of oligoclonal IgG bands in tears and in cerebrospinal fluid by isoelectric focusing in patients with clinically isolated syndrome |  | two years after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of isoelectric focusing of tears | Identification of the number of patients with a typical electrophoretic profile in tears allowing the early diagnosis of a SEP-RR | inclusion, two years after | 
| Concordance between visual and automatic reading of electrophoretic profiles | Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Clinically Isolated Syndrome, Tears, Isoelectric focusing, Oligoclonal profile