An interventional study of Tear collection and lumbar punction in Clinically Isolated Syndrome, Radiologically Isolated Syndrome and Multiple Sclerosis in Children, sponsored by Lille Catholic University. Recruiting at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Lille Catholic University is the lead sponsor of 111 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the RIS population:
For the CIS population:
Exclusion Criteria:
The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed
Diagnostic Test: Tear collection and lumbar punction
Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands
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
Time frame: Day 0
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
Time frame: Day 0
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
Time frame: Day 0
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
Time frame: Day 0
Proportion of patients with OCBs in tears
Time frame: day 0, one year
Plan to share: No
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