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Набор по приглашению NCT07183020

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

— Наблюдательное Multiple Sclerosis Clinically Isolated Syndrome (CIS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oligoclonal bands and kappa free light chains (KFLC).
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Clinically Isolated Syndrome (CIS). Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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)

Первичные конечные точки

  • 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 [Срок оценки: From study inclusion to the final analysis of cerebrospinal fluid (CSF) oligoclonal bands and kappa free light chains (KFLC) at 12 months]
Вторичные конечные точки (1)
  • Superiority of Reiber´s diagram for kappa free light chains (KFLC) compared to KFLC index of 6.1 to assess for an intrathecal KFLC synthesis in multiple sclerosis (MS) and clinically isolated syndrome (CIS) patients [Срок оценки: From study inclusion to the final analysis of cerebrospinal fluid (CSF) oligoclonal bands and kappa free light chains (KFLC) at 12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Medizinische Hochschule Hannover / Hannover Medical School — Hanover

Публикации

  • 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. PMID 30501024
  • 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. PMID 31744096
  • 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. PMID 32244362
  • 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. PMID 34831279
  • 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. PMID 35328273
  • 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. PMID 35448006
  • 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. PMID 35884934
  • 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. PMID 39039726

Идентификаторы

NCT: NCT07183020 · 10167_B0_K2022

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗