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

Lille Catholic University

Status: Enrolling

Conditions: Radiologically Isolated Syndrome; Multiple Sclerosis in Children; Clinically Isolated Syndrome

Treatments: Diagnostic Test: Tear collection and lumbar punction

Study type: Interventional

Funder types: Other

Identifiers

NCT03979391

RC-P0070

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Children with CIS or RIS

Experimental group

Description:

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

Treatment:

Diagnostic Test: Tear collection and lumbar punction