Kappa Free Light Chains (KFLC) in Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS)

Condition(s) studied

Investigational drug(s) / intervention(s)

Oligoclonal bands and kappa free light chains (KFLC): Comparison of oligoclonal bands and kappa free light chains (KFLC) in patients with multiple sclerosis (MS) / clinically isolated syndrome (CIS)

Study summary

The goal of this observational study is to learn about the role of kappa free light chains (KFLC) in cerebrospinal fluid (CSF) in the diagnosis of multiple sclerosis (MS) and clinically isolated syndrome (CIS). The main question it aims to answer is:

Are KFLC superior, inferior or equally useful in the diagnostic work-up of CSF of patients with MS and CIS?

In CSF and serum sample pairs of patients diagnosed with MS or CIS, KFLC are measured using a nephelometric assay and are compared with the gold standard, of CSF diagnostics, oligoclonal bands.

Eligibility

Primary outcome measure(s)

• Non-inferiority of diagnostic sensitivity of cerebrospinal fluid (CSF) kappa free light chains (KFLC) in multiple sclerosis (MS) and clinically isolated syndrome (CIS) compared to oligoclonal bands — From study inclusion to the final analysis of cerebrospinal fluid (CSF) oligoclonal bands and kappa free light chains (KFLC) at 12 months
  Evidence of an intrathecal kappa free light chains (KFLC) synthesis is equally sensitive to assess for an intrathecal immunglobulin synthesis compared with oligoclonal bands

Trial sites (1)

Other trials for the same condition