Clinical Trial

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

Study acronym: PRO-KFLC
Enrolling by Invitation
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Record status
This record was last updated September 19, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07183020
Lead Sponsor Skripuletz, Thomas Prof. Dr.
Conditions Multiple Sclerosis, Clinically Isolated Syndrome (CIS)
Enrollment 1,142 participants
Start Date 2022-10-27
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-19