Clinical trial NCT05088473: Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases
Official title: Diagnosic and Pronostic Values of Kappa and Lambda Free Light Chains in Central Nervous System Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Diseases
Multiple Sclerosis
Keywords: multiple sclerosis
kappa free light chains
lambda free light chains
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with symptoms evocative of CNS disease

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.


Eligibility 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)

Primary outcomes:
measure: Measurement of cerebrospinal fluid (CSF) and serum kappa and lambda free light chains (KFLC and LFLC)
timeFrame: 1 day
measure: Measurement of cerebrospinal fluid (CSF) and serum albumin
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: Comparison of diagnostic performances of K/L FLC intrathecal synthesis biomarkers to oligoclonal bands (OCB) for multiple sclerosis
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of clinical data that can alter KFLC and LFLC values
timeFrame: 1 day
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Marseille
country: France
facility: Assistance Publique des Hôpitaux de Marseille
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Paris
country: France
facility: Assistance Publique des Hôpitaux de Paris
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Tours
country: France
facility: Centre Hospitalier Régional et Universaitaire de Tours
Study officials:
References: