Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-05-31

Brief Summary

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To:

1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .
2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis)

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Detailed Description

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Multiple sclerosis is a chronic inflammatory immune-mediated disorder of the central nervous system.Diagnosis requires the combination of clinical signs and symptoms with paraclinical findings obtained by magnetic resonance imaging and cerebrospinal fluid analysis .which are componants of the 2017 McDonald criteria .So far, the gold standard for demonstrating intrathecal IgG synthesis is represented by selective oligoclonal bands in cerebrospinal fluid by isoelectric focusing (IEF), alongside an elevated IgG index .However, the detection of oligoclonal bands in cerebrospinal fluid has several limits as , it requires a time-consuming and expensive laboratory technique, with about three hours needed to obtain results Furthermore, it only provides aqualitative information about the presence of IgG in CSF .During CNS inflammation , kappa free light chain are secreted in the CSF and their concentration reflect the degree of intrathecal B cells and plasma cells activation .Measurement of KFLC could help diagnosis of OCB negative MS and identify intrathecal immunoglobulin synthesis in patient presenting with one isolated band on isoelectric focusing , and it is fully automated,rater independent, stable against preanalytical errors . Thus, the intrathecal synthesis of free light chains are more sensitive, less costly, and less time-consuming compared To OCB detection .The most reliable parameter used to assess FLC diagnostic value in MS is the k-index, .So κ-FLC index predicted the time to conversion to MS as well as disability progression . So patients with early MS and high κ-FLC index is an independent risk factor for conversion from CIS to MS

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

(-ve OCB )(70 patients) Control group which include patients with inflammatory and non-inflammatory neurological diseases (such as cerebral small vessel disease or unspecific white matter lesion )

kappa index

Intervention Type DIAGNOSTIC_TEST

CSF albumin /serum albumin ratio (Qalb) k-index = (CSF kFLC/serum kFLC)/Qalb

2

(+ve OCBs )(70 patients) Patients presenting for the diagnostic workup, including CSF analysis , of clinical and/or MRI suspicion of MS or CIS.

kappa index

Intervention Type DIAGNOSTIC_TEST

CSF albumin /serum albumin ratio (Qalb) k-index = (CSF kFLC/serum kFLC)/Qalb

Interventions

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kappa index

CSF albumin /serum albumin ratio (Qalb) k-index = (CSF kFLC/serum kFLC)/Qalb

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with CIS or MS according to the 2017 revision of the McDonald criteria
* Patients diagnosed with RIS (Radiological isolated syndrome) according to the criteria by Okuda
* Age between 18 and 40 years.

Exclusion Criteria

* History of exposure, in the 30 days prior to CSF collection, to immunosuppressant or immunomodulatory therapies .
* Peripheral neurological disorders .
* Infectious CNS disease.
* CNS tumor.
* Monoclonal gammopathy .
* Chronic kidney injury (GFR \<30 ml /min/1.75m2 )

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No