Spinal fluid immunoglobulin free light chains to predict multiple sclerosis course
Prognostic Value of Cerebrospinal Fluid Immunoglobulin Free Light Chains in Patients With Multiple Sclerosis
Brugmann University Hospital · NCT05072691
This will test whether measuring immunoglobulin free light chains in spinal fluid can help predict future disease course in adults with multiple sclerosis or optic neuritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brugmann University Hospital (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05072691 on ClinicalTrials.gov |
What this trial studies
This observational study will measure cerebrospinal fluid (CSF) immunoglobulin free light chains (FLC) in adults diagnosed with multiple sclerosis by the 2017 McDonald criteria or with optic neuritis who are undergoing lumbar puncture and brain MRI as part of routine care. FLC levels will be compared with oligoclonal band status and correlated with clinical outcomes including conversion from clinically isolated syndrome to definite MS and disability measured by the Expanded Disability Status Scale (EDSS). The protocol uses quantitative FLC assays to address reproducibility and dynamic range limitations of OCB testing. Routine clinical follow-up and imaging data will be used to determine whether baseline CSF FLC predicts longer-term disease course.
Who should consider this trial
Good fit: Adults (≥18) with multiple sclerosis according to the 2017 McDonald criteria or with optic neuritis who are undergoing lumbar puncture and brain MRI as part of their diagnostic work-up are ideal candidates.
Not a fit: Patients who do not undergo lumbar puncture, lack follow-up clinical or MRI data, or have alternative neurological diagnoses are unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, this could provide a quantitative spinal fluid marker to better predict disease course and help personalize treatment decisions.
How similar studies have performed: Small prior studies have shown CSF free light chains can be more sensitive and specific than oligoclonal bands for diagnosing MS and have suggested prognostic value, but large prospective validation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 at the time of enrollment * Diagnosis of multiple sclerosis according to 2017 McDonald diagnostic criteria or optic neuritis (fulfilling or not criteria for multiple sclerosis, i.e. clinically isolated syndrome) * Receiving both lumbar puncture and brain MRI for the routine diagnostic work-up Exclusion Criteria: • None
Where this trial is running
Brussels
- CHU Brugmann — Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Serena Borrelli — CHU Brugmann
- Study coordinator: Serena Borrelli, MD
- Email: Serena.BORRELLI@chu-brugmann.be
- Phone: 3224750308
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: Multiple Sclerosis