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Isoelectric Focusing of Tears in Children With Radiologically Isolated or Clinically Isolated Syndrome (OBIT)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Clinically Isolated Syndrome Radiologically Isolated Syndrome Multiple Sclerosis in Children | Diagnostic Test: Tear collection and lumbar punction | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | September 26, 2019 |
| Estimated Primary Completion Date : | September 26, 2021 |
| Estimated Study Completion Date : | September 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Children with CIS or RIS
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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS [ Time Frame: 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
- Proportion of patients with OCBs in tears [ Time Frame: day 0, one year ]
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Lansiaux Amelie, MD, PhD | 03.20.22.52.69 | lansiaux.amelie@ghicl.net | |
| Contact: Boulafa Amel | 03.20.22.52.69 | boulafa.amel@ghicl.net |
| France | |
| GHICL | Recruiting |
| Lomme, France, 59462 | |
| Contact: Amelie Lansiaux, MD, PhD 00 33 3.20.22.57.41 lansiaux.amelie@ghicl.net | |
| Contact: Melanie Hamez 00 33 3.20.22.57.31 hamez.melanie@ghicl.net | |
| Principal Investigator: | Hautecoeur Patrick | Lille Catholic University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 3, 2019 | ||||||||
| First Posted Date ICMJE | June 7, 2019 | ||||||||
| Last Update Posted Date | March 3, 2020 | ||||||||
| Actual Study Start Date ICMJE | September 26, 2019 | ||||||||
| Estimated Primary Completion Date | September 26, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Proportion of patients with OCBs in tears [ Time Frame: day 0, one year ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Isoelectric Focusing of Tears in Children With Radiologically Isolated or Clinically Isolated Syndrome | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Diagnostic Test: Tear collection and lumbar punction
Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands
|
||||||||
| Study Arms ICMJE | Experimental: Children with CIS or RIS
The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed
Intervention: Diagnostic Test: Tear collection and lumbar punction
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 1, 2023 | ||||||||
| Estimated Primary Completion Date | September 26, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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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| Sex/Gender ICMJE |
|
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| Ages ICMJE | up to 18 Years (Child, Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03979391 | ||||||||
| Other Study ID Numbers ICMJE | RC-P0070 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Lille Catholic University | ||||||||
| Study Sponsor ICMJE | Lille Catholic University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Lille Catholic University | ||||||||
| Verification Date | March 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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