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Completed

NCT Number: NCT05088473

Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases

Numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. However, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. Therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.

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Key information

Conditions

Central Nervous System Diseases Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting with symptoms evocative of CNS involvement for who serum and cerebrospinal fluid kappa free light chains and kappa index are available

Exclusion criteria

  • Infectious CNS disease
  • Tumor CNS disease
  • Active CNS bleeding
  • Monoclonal gammapathy
  • Severe chronic renal failure (glomerular filtration rate <30 ml/mn)

Treatment and study plan

Biological collection

Other

Collection of cerebrospinal fluid kappa and lambda free light chains and indexes

Primary outcomes

  1. Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC)

    Time frame: 1 day

    • Measurement of cerebrospinal fluid (CSF) and serum KFLC and LFLC by a turbilimetric analyzer (data in mg/L)
    • Quantification of QKFLC and QLFLC (CSF FLC/serum FLC) in each group of patients
    • Compare median of QKFLC and QLFLC between groups

  2. Measurement of cerebrospinal fluid (CSF) and serum albumin

    Time frame: 1 day

    • Measurement of cerebrospinal fluid (CSF) and serum albumin by the same turbilimetric analyzer (data in mg/L)
    • Quantification of albumin quotient (AQ) (CSF albumin/serum albumin) in each group of patients

  3. Evaluation of the diagnostic performances of KFLC and LFLC intrathecal synthesis biomarkers (K/L FLC index and K/L FLC intrathecal fraction (IF)) for multiple sclerosis

    Time frame: 1 day

    • Calculation of KFLC intrathecal synthesis biomarkers:

    KFLC index = (CSF KFLC/serum KFLC) / AQ

    KFLC IF = (KFLC(loc)/CSF KFLC) x 100 with:

    KFLC(loc) = ((CSF KFLC/serum KFLC) / Qk(lim)) x serum KFLC and Qk(lim) = 3.27 x (AQ^2 + 33)^0.5 - 8.2

    • Calculation of LFLC intrathecal synthesis biomarkers:

    LFLC index = (CSF LFLC/serum LFLC) / AQ)

    LFLC IF = (LFLC(loc)/CSF LFLC) x 100 with:

    LFLC(loc) = ((CSF LFLC/serum LFLC) / Ql(lim)) x serum LFLC and Ql(lim) = 2.1138 x AQ^0.865

    • Determination of diagnostic performances by ROC curve analysis and best cut-off values with the Younden index to calculate sensitivity, specificity and predictive values for MS diagnosis

  4. Comparison of diagnostic performances of K/L FLC intrathecal synthesis biomarkers to oligoclonal bands (OCB) for multiple sclerosis

    Time frame: 1 day

    • Identification of OCB status for each patient
    • Calculation of diagnostic performances of OCB (sensitivity, specificity and predictive values) for MS diagnostic
    • Comparison of diagnostic performances (sensitivity, specificity and predictive values) of OCB and K/L FLC intrathecal synthesis biomarkers for multiple sclerosis

Secondary outcomes

  1. Evaluation of clinical data that can alter KFLC and LFLC values

    Time frame: 1 day

    Identification of data that can be independtly associated with high or low CSF KFLC or LFLC values as potential bias in K/L FLC intrathecal synthesis biomarkers interpretation:

    • Gender
    • Age
    • Type of clinical demyelinating event (i.e. myelitis, optic neuritis...)
    • Immune modifying drug treatment ongoing during sampling
    • Underlying disease activity (measured by the presence of subacute clinical symptoms ongoing at sampling or gadolinium enhanced lesions within the last MRI status)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2021
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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