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

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ClinicalTrials.gov Identifier: NCT05088473
Recruitment Status : Completed
First Posted : October 22, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Central Nervous System Diseases Multiple Sclerosis Other: Biological collection

Study Design
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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases
Actual Study Start Date : October 15, 2021
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Mutliple sclerosis Other: Biological collection
Collection of cerebrospinal fluid kappa and lambda free light chains and indexes
CIS/RIS Other: Biological collection
Collection of cerebrospinal fluid kappa and lambda free light chains and indexes
Other CNS inflammatory diseases Other: Biological collection
Collection of cerebrospinal fluid kappa and lambda free light chains and indexes
Non inflammatory CNS diseases Other: Biological collection
Collection of cerebrospinal fluid kappa and lambda free light chains and indexes


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC) [ Time Frame: 1 day ]
    1. Measurement of cerebrospinal fluid (CSF) and serum KFLC and LFLC by a turbilimetric analyzer (data in mg/L)
    2. Quantification of QKFLC and QLFLC (CSF FLC/serum FLC) in each group of patients
    3. Compare median of QKFLC and QLFLC between groups

  2. Measurement of cerebrospinal fluid (CSF) and serum albumin [ Time Frame: 1 day ]
    1. Measurement of cerebrospinal fluid (CSF) and serum albumin by the same turbilimetric analyzer (data in mg/L)
    2. 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 ]

    1. 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

    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

    3. 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 ]
    1. Identification of OCB status for each patient
    2. Calculation of diagnostic performances of OCB (sensitivity, specificity and predictive values) for MS diagnostic
    3. Comparison of diagnostic performances (sensitivity, specificity and predictive values) of OCB and K/L FLC intrathecal synthesis biomarkers for multiple sclerosis


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with symptoms evocative of CNS disease
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05088473


Locations
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France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
Centre Hospitalier Universitaire de Dijon
Dijon, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, France
Centre Hospitalier Universitaire de Lille
Lille, France
Assistance Publique des Hôpitaux de Marseille
Marseille, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Centre Hospitalier Universitaire de Nice
Nice, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France
Assistance Publique des Hôpitaux de Paris
Paris, France
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Étienne, France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Centre Hospitalier Régional et Universaitaire de Tours
Tours, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT05088473    
Other Study ID Numbers: 21Neuro01
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
multiple sclerosis
kappa free light chains
lambda free light chains
Additional relevant MeSH terms:
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Multiple Sclerosis
Nervous System Diseases
Central Nervous System Diseases
Sclerosis
Pathologic Processes
 Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases