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

Status unknownNot a drug-phase studyEarly (CIS/RIS)NCT03979391

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Tear collection and lumbar punction

What it measured

Main measures

  • Sensitivity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS

    Day 0

  • Specificity of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS

    Day 0

  • Positive predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS

    Day 0

  • Negative predictive value of tears analysis compared to lumbar punction analysis for the diagnosis of CIS and RIS

    Day 0

Other measures (1)

  • Proportion of patients with OCBs in tears

    day 0, one year

Who could take part

Early (CIS/RIS) · Up to 18

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Sept 2019

    2. Main results due

      Nov 2024

    3. Finished

      Nov 2024

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