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

Last updated: September 12, 2023
Sponsor: Lille Catholic University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Radiologically Isolated Syndrome

Multiple Sclerosis

Neurologic Disorders

Treatment

Tear collection and lumbar punction

Clinical Study ID

NCT03979391
RC-P0070
  • Ages < 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age < 18 years old

  • informed consent from the child and the parents (at least one of the two legalguardians)

  • child covered by social security For the RIS population:

  • asymptomatic child

  • fortuitous discovery of lesions strongly suggesting sclerosis multiple on a Magneticresonance imaging (MRI) scan For the CIS population:

  • child presenting a CIS in the past three months

Exclusion

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 treatmentof another disease than MS

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Tear collection and lumbar punction
Phase:
Study Start date:
September 26, 2019
Estimated Completion Date:
November 26, 2024

Study 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.

Connect with a study center

  • GHICL

    Lomme, 59462
    France

    Active - Recruiting

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