Isoelectric Focusing of Tears in Children With Radiologically Isolated or Clinically Isolated Syndrome

Study Overview
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Brief Summary
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The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.

Detailed Description
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Multiple Sclerosis (MS) is a disease that affects the white matter of the central nervous system. In France, approximately 100,000 patients are affected. It is one of the most common neurological condition in young adults. The presence of supernumerary oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF) in comparison to the serum was established in 2017 as a criterion for temporal dissemination in MS patients. This is a predictive factor of conversion to MS in the clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS), either in children or adults. However, the main inconvenient of OCB analysis in CSF is the requirement of a lumbar puncture, which is a traumatising technique that may raise ethical concerns especially when it has to be performed in children. Searching for OCBs in tears, which are more accessible, may represent an attractive alternative. Some published articles studying adult populations go in this direction, but there are no data in the literature regarding children. The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.

Official Title
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Detecting Oligoclonal Bands Through Isoelectric Focusing of Tears in Children With Radiologically Isolated Syndrome or Clinically Isolated Syndrome: a Diagnostic, Prospective, Multicentric Study With a 2-year Longitudinal Follow-up

Conditions
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Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis in Children

Intervention / Treatment
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* Diagnostic Test: Tear collection and lumbar punction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age < 18 years old informed consent from the child and the parents (at least one of the two legal guardians) child covered by social security For the RIS population: asymptomatic child fortuitous discovery of lesions strongly suggesting sclerosis multiple on a Magnetic resonance imaging (MRI) scan For the CIS population: - child presenting a CIS in the past three months Exclusion Criteria: patient with remitting MS patient with progressive MS patient with eye infection patient under immunosuppressive therapy on the day of inclusion due to the treatment of another disease than MS

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with CIS or RIS<br>The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed | Diagnostic Test: Tear collection and lumbar punction<br>* Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS | To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis | Day 0 | 
| Specificity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS | To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis | Day 0 | 
| Positive predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS | To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis | Day 0 | 
| Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS | To evaluate the diagnostic performance of tears analysis in children with CIS and RIS, (sensitivity, specificity, positive and negative predictive value) being the gold standard the cerebrospinal analysis | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with OCBs in tears |  | day 0, one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis, Children, Tear analysis