Clinical trial NCT03979391: Isoelectric Focusing of Tears in Children With Radiologically Isolated or Clinically Isolated Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinically Isolated Syndrome
Radiologically Isolated Syndrome
Multiple Sclerosis in Children
Keywords: Clinically Isolated Syndrome
Radiologically Isolated Syndrome
Multiple Sclerosis
Children
Tear analysis
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
timeFrame: Day 0
measure: Specificity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
timeFrame: Day 0
measure: Positive predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
timeFrame: Day 0
measure: Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS
timeFrame: Day 0
Secondary outcomes:
measure: Proportion of patients with OCBs in tears
timeFrame: day 0, one year
Other outcomes:
Locations:
city: Lomme
country: France
facility: GHICL
Study officials:
affiliation: Lille Catholic University
name: Hautecoeur Patrick
role: PRINCIPAL_INVESTIGATOR
References: