Kappa Free Light Chains (KFLC) in Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS)
NCT ID: NCT07183020
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1142 participants
OBSERVATIONAL
2022-10-27
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Multiple sclerosis (MS) / clinically isolated syndrome (CIS)
Patients diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS) and an available pair of cerebrospinal fluid (CSF) and serum
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* age between 18 and 70 years
Exclusion Criteria
* no available cerebrospinal fluid (CSF) and serum sample pairs
18 Years
70 Years
ALL
No
Sponsors
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Skripuletz, Thomas Prof. Dr.
OTHER
Responsible Party
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Skripuletz, Thomas Prof. Dr.
Prof. Dr. med., MD
Locations
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Medizinische Hochschule Hannover / Hannover Medical School
Hanover, Lower Saxony, Germany
Countries
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References
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Schwenkenbecher P, Konen FF, Wurster U, Jendretzky KF, Gingele S, Suhs KW, Pul R, Witte T, Stangel M, Skripuletz T. The Persisting Significance of Oligoclonal Bands in the Dawning Era of Kappa Free Light Chains for the Diagnosis of Multiple Sclerosis. Int J Mol Sci. 2018 Nov 29;19(12):3796. doi: 10.3390/ijms19123796.
Schwenkenbecher P, Konen FF, Wurster U, Witte T, Gingele S, Suhs KW, Stangel M, Skripuletz T. Reiber's Diagram for Kappa Free Light Chains: The New Standard for Assessing Intrathecal Synthesis? Diagnostics (Basel). 2019 Nov 16;9(4):194. doi: 10.3390/diagnostics9040194.
Konen FF, Wurster U, Witte T, Jendretzky KF, Gingele S, Tumani H, Suhs KW, Stangel M, Schwenkenbecher P, Skripuletz T. The Impact of Immunomodulatory Treatment on Kappa Free Light Chains as Biomarker in Neuroinflammation. Cells. 2020 Mar 31;9(4):842. doi: 10.3390/cells9040842.
Konen FF, Schwenkenbecher P, Jendretzky KF, Gingele S, Suhs KW, Tumani H, Susse M, Skripuletz T. The Increasing Role of Kappa Free Light Chains in the Diagnosis of Multiple Sclerosis. Cells. 2021 Nov 6;10(11):3056. doi: 10.3390/cells10113056.
Susse M, Konen FF, Schwenkenbecher P, Budde K, Nauck M, Grothe M, Hannich MJ, Skripuletz T. Decreased Intrathecal Concentrations of Free Light Chains Kappa in Multiple Sclerosis Patients Taking Very High Effective Disease-Modifying Treatment. Diagnostics (Basel). 2022 Mar 16;12(3):720. doi: 10.3390/diagnostics12030720.
Konen FF, Schwenkenbecher P, Jendretzky KF, Gingele S, Witte T, Suhs KW, Grothe M, Hannich MJ, Susse M, Skripuletz T. Kappa Free Light Chains in Cerebrospinal Fluid in Inflammatory and Non-Inflammatory Neurological Diseases. Brain Sci. 2022 Apr 3;12(4):475. doi: 10.3390/brainsci12040475.
Konen FF, Hannich MJ, Schwenkenbecher P, Grothe M, Gag K, Jendretzky KF, Gingele S, Suhs KW, Witte T, Skripuletz T, Susse M. Diagnostic Cerebrospinal Fluid Biomarker in Early and Late Onset Multiple Sclerosis. Biomedicines. 2022 Jul 7;10(7):1629. doi: 10.3390/biomedicines10071629.
Hannich MJ, Konen FF, Gag K, Alkhayer A, Turker SN, Budde K, Nauck M, Wurster U, Dressel A, Skripuletz T, Susse M. Implications of monoclonal gammopathy and isoelectric focusing pattern 5 on the free light chain kappa diagnostics in cerebrospinal fluid. Clin Chem Lab Med. 2024 Jul 23;63(1):147-153. doi: 10.1515/cclm-2023-1468. Print 2025 Jan 29.
Konen FF, Wurster U, Schwenkenbecher P, Gerritzen A, Gross CC, Eichhorn P, Harrer A, Isenmann S, Lewczuk P, Lewerenz J, Leypoldt F, Otto M, Regeniter A, Roskos M, Ruprecht K, Spreer A, Strik H, Uhr M, Wick M, Wildemann B, Wiltfang J, Zimmermann T, Hannich M, Khalil M, Tumani H, Susse M, Skripuletz T; German Society for Cerebrospinal Fluid Diagnostics and Clinical Neurochemistry (DGLN e.V.). Oligoclonal bands and kappa free light chains: Competing parameters or complementary biomarkers? Autoimmun Rev. 2025 Apr 30;24(5):103765. doi: 10.1016/j.autrev.2025.103765. Epub 2025 Feb 11.
Other Identifiers
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10167_B0_K2022
Identifier Type: -
Identifier Source: org_study_id
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