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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2024-11-26

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.

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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.

Conditions

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Clinically Isolated Syndrome Radiologically Isolated Syndrome Multiple Sclerosis in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Children with CIS or RIS

The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed

Group Type EXPERIMENTAL

Tear collection and lumbar punction

Intervention Type DIAGNOSTIC_TEST

Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands

Interventions

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Tear collection and lumbar punction

Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands

Intervention Type DIAGNOSTIC_TEST

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No