Clinically Isolated Syndrome, Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Clinically Isolated Syndrome, Tears, Isoelectric focusing, Oligoclonal profile
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.
Interventions
PROCEDUREtears and cerebrospinal fluid sampling
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.
Sponsors
Lille Catholic University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid | two years after | Test of the concordance coefficient between the analysis of tears and the analysis of cerebrospinal fluid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of isoelectric focusing of tears | inclusion, two years after | Identification of the number of patients with a typical electrophoretic profile in tears allowing the early diagnosis of a SEP-RR |
| Concordance between visual and automatic reading of electrophoretic profiles | two years | Determination of percentage of positive and negative tests after visual and automatic reading of electrophoretic profiles |
| Calculation of sensitivity/specificity | two years | Calculation of sensitivity/specificity |
| Calculation of positive/negative predictive value | two years | Calculation of positive/negative predictive value |
| Calculation of efficiency odds ratio | two years | Calculation of efficiency odds ratio |
Countries
France
Outcome results
None listed