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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979391
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Lille Catholic University

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.

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

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 : 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Proportion of patients with OCBs in tears [ Time Frame: day 0, one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979391


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Lille Catholic University
Investigators
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Principal Investigator: Hautecoeur Patrick Lille Catholic University
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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03979391    
Other Study ID Numbers: RC-P0070
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lille Catholic University:
Clinically Isolated Syndrome
Radiologically Isolated Syndrome
Multiple Sclerosis
Children
Tear analysis
Additional relevant MeSH terms:
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Multiple Sclerosis
Syndrome
Sclerosis
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases