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

NCT05088473 | Completed

• 1 other identifier: 21Neuro01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 14

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.

Conditions

Central Nervous System Diseases; Multiple Sclerosis

Keywords

multiple sclerosis; kappa free light chains; lambda free light chains

Outcome Measures

Primary Outcomes (4)

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

  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

  1 day

• Measurement of cerebrospinal fluid (CSF) and serum albumin

  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

  1 day

• 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

  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

  1 day

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

  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

  1 day

Secondary Outcomes (1)

• Evaluation of clinical data that can alter KFLC and LFLC values

  1 day

Study Arms (4)

Mutliple sclerosis

Other: Biological collection

CIS/RIS

Other: Biological collection

Other CNS inflammatory diseases

Other: Biological collection

Non inflammatory CNS diseases

Other: Biological collection

Interventions

Biological collection OTHER

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

CIS/RIS; Mutliple sclerosis; Non inflammatory CNS diseases; Other CNS inflammatory diseases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with symptoms evocative of CNS disease

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (14)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, France

Location

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

Location

Centre Hospitalier Universitaire de Lille

Lille, France

Location

Assistance Publique des Hôpitaux de Marseille

Marseille, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

Centre Hospitalier Universitaire de Nice

Nice, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, France

Location

Assistance Publique des Hôpitaux de Paris

Paris, France

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, France

Location

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Centre Hospitalier Régional et Universaitaire de Tours

Tours, France

Location

MeSH Terms

Conditions

Central Nervous System Diseases; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: October 22, 2021
• Study Start: October 15, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)