Analyzing tears in children with isolated syndrome to improve diagnosis
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
NA · Lille Catholic University · NCT03979391
This study is testing whether analyzing tears can help doctors diagnose children with isolated syndrome and predict if they will develop multiple sclerosis, offering a less painful option than spinal taps.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Lille Catholic University (other) |
| Locations | 1 site (Lomme) |
| Trial ID | NCT03979391 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the diagnostic quality of tears in children diagnosed with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) through a multicentric, prospective approach. By analyzing the presence of oligoclonal bands (OCBs) in tears, the study seeks to provide a less invasive alternative to lumbar punctures, which are often distressing for pediatric patients. The research will involve longitudinal follow-up to assess the effectiveness of tear analysis in predicting the conversion to multiple sclerosis. This innovative approach could potentially change the way these conditions are diagnosed in children.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who have either clinically isolated syndrome or radiologically isolated syndrome.
Not a fit: Patients with remitting or progressive multiple sclerosis, eye infections, or those undergoing immunosuppressive therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible diagnostic method for early detection of multiple sclerosis in children.
How similar studies have performed: While there have been studies on tear analysis in adults, this approach in children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lomme
- GHICL — Lomme, France (RECRUITING)
Study contacts
- Principal investigator: Hautecoeur Patrick — Lille Catholic University
- Study coordinator: Lebitasy Marie Paule, PhD
- Email: Lebitasy.Marie-Paule@ghicl.net
- Phone: 03.20.22.57.41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clinically Isolated Syndrome, Radiologically Isolated Syndrome, Multiple Sclerosis in Children, Multiple Sclerosis, Children, Tear analysis