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

Clinically Isolated Syndrome Clinical Trial

— OBIT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03979391
• Other study ID #: RC-P0070
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: November 26, 2024

Study information

• Verified date: September 2023
• Source: Lille Catholic University
• Contact: Lebitasy Marie Paule, PhD
• Phone: 03.20.22.57.41
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 26, 2024
• Est. primary completion date: November 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Multiple Sclerosis in Children
• Radiologically Isolated Syndrome
• Sclerosis
• Syndrome

Intervention

Diagnostic Test:
• Tear collection and lumbar punction
Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands

Locations

Country	Name	City	State
France	GHICL	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	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	Day 0
Primary	Specificity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	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	Day 0
Primary	Positive predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	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	Day 0
Primary	Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS	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	Day 0
Secondary	Proportion of patients with OCBs in tears		day 0, one year