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

Not Applicable

Recruiting

• Conditions: Clinically Isolated Syndrome; Multiple Sclerosis in Children; Radiologically Isolated Syndrome
• Interventions: Diagnostic Test: Tear collection and lumbar punction

• Registration Number: NCT03979391
• Lead Sponsor: Lille Catholic University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-09-26
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-11-26
• Study Completion: 2024-11-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with CIS or RIS	Tear collection and lumbar punction	The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed

Primary Outcome Measures

Name	Time	Method
Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	Day 0	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
Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	Day 0	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
Specificity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	Day 0	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
Positive predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	Day 0	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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with OCBs in tears	day 0, one year

Trial Locations

Locations (1)

GHICL; 🇫🇷 Lomme, France