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

Skripuletz, Thomas Prof. Dr.

Status: Invitation-only

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome (CIS)

Treatments: Diagnostic Test: Oligoclonal bands and kappa free light chains (KFLC)

Study type: Observational

Funder types: Other

Identifiers

NCT07183020

10167_B0_K2022

Details and patient eligibility

About

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.

Full description

In this multicenter study, paired cerebrospinal fluid (CSF) and serum samples from patients with chronic inflammatory diseases of the central nervous system (multiple sclerosis (MS) / clinically isolated syndrome (CIS)) are investigated to evaluate the diagnostic utility of CSF-specific oligoclonal bands and kappa free light chains (KFLC). Both biomarkers have already demonstrated diagnostic relevance in this patient population, but comparative multicenter studies are still lacking. Another key challenge for the clinical implementation of KFLC is the absence of standardized reference values, as different cut-offs were proposed.

To address this gap, CSF-specific oligoclonal bands and KFLC are prospectively analyzed in a multicenter cohort of patients with MS / CIS. Samples and associated data are collected prospectively and partially retrospectively from participating centers. Included patients are followed longitudinally to determine whether conversion from CIS to clinical definite MS occurs and to monitor disease progression over time.

Enrollment: 1,142 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS) according to 2017-revised McDonald criteria for MS
• age between 18 and 70 years

Exclusion criteria

• no diagnosis of MS or CIS according to 2017-revised McDonald criteria for MS
• no available cerebrospinal fluid (CSF) and serum sample pairs

Trial design

1,142 participants in 1 patient group

Multiple sclerosis (MS) / clinically isolated syndrome (CIS)

Description:

Patients diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS) and an available pair of cerebrospinal fluid (CSF) and serum

Treatment:

Diagnostic Test: Oligoclonal bands and kappa free light chains (KFLC)