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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with CIS or RIS | Experimental | The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tear collection and lumbar punction | Diagnostic Test | Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with OCBs in tears | day 0, one year |
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Inclusion Criteria:
For the RIS population:
For the CIS population:
- child presenting a CIS in the past three months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lebitasy Marie Paule, PhD | Contact | 03.20.22.57.41 | Lebitasy.Marie-Paule@ghicl.net |
| Name | Affiliation | Role |
|---|---|---|
| Hautecoeur Patrick | Lille Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHICL | Recruiting | Lomme | 59462 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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