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ENROLLING BY INVITATION
NCT07183020

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

Sponsor: Skripuletz, Thomas Prof. Dr.

View on ClinicalTrials.gov

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.

Official title: Prospective, Multicentric, Real-world Investigation of Kappa Free Light Chains (KFLC) in Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

1142

Start Date

2022-10-27

Completion Date

2026-12-31

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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)

Locations (1)

Medizinische Hochschule Hannover / Hannover Medical School

Hanover, Lower Saxony, Germany