NCT03979391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

5.2 years

First QC Date

June 3, 2019

Last Update Submit

September 12, 2023

Conditions

Clinically Isolated SyndromeRadiologically Isolated SyndromeMultiple Sclerosis in Children

Keywords

Clinically Isolated SyndromeRadiologically Isolated SyndromeMultiple SclerosisChildrenTear analysis

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (1)

  • Proportion of patients with OCBs in tears

    day 0, one year

Study Arms (1)

Children with CIS or RIS

EXPERIMENTAL

The detection of supernumerary oligoclonal bands (OCBs) in tears will be performed

Diagnostic Test: Tear collection and lumbar punction

Interventions

Tear collection and lumbar punctionDIAGNOSTIC_TEST

Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands

Children with CIS or RIS

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • patient with remitting MS
  • patient with progressive MS
  • patient with eye infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHICL

Lomme, 59462, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Hautecoeur Patrick

    Lille Catholic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lebitasy Marie Paule, PhD

CONTACT

03.20.22.57.41Lebitasy.Marie-Paule@ghicl.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 7, 2019

Study Start

September 26, 2019

Primary Completion

November 26, 2024

Study Completion

November 26, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)