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

Multiple Sclerosis Clinical Trial

Official title:

Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of Multiple Sclerosis and Prediction of Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372977
• Other study ID #: kappa index in ms
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: reham abdelsater, assistant lecturer
• Phone: 01024478076
• Email: rehamabdelsater[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: May 2026
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• kappa index
CSF albumin /serum albumin ratio (Qalb) k-index = (CSF kFLC/serum kFLC)/Qalb

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Duell F, Evertsson B, Al Nimer F, Sandin A, Olsson D, Olsson T, Khademi M, Hietala MA, Piehl F, Hansson M. Diagnostic accuracy of intrathecal kappa free light chains compared with OCBs in MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 11;7(4):e775. doi: 10.1212/NXI.0000000000000775. Print 2020 Jul. — View Citation

Gaetani L, Di Carlo M, Brachelente G, Valletta F, Eusebi P, Mancini A, Gentili L, Borrelli A, Calabresi P, Sarchielli P, Ferri C, Villa A, Di Filippo M. Cerebrospinal fluid free light chains compared to oligoclonal bands as biomarkers in multiple sclerosis. J Neuroimmunol. 2020 Feb 15;339:577108. doi: 10.1016/j.jneuroim.2019.577108. Epub 2019 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases .	measure specificity and sensitivity of kappa free light chain	baseline
Primary	Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases .	measure specificity and sensitivity of cerebrospinal fluid oligoclonal bands	baseline
Secondary	Assess the role of k FLC in predicting disease activity (conversion from CIS to MS)	measure positive predictive value and negative predictive value of kappa free light chain	baseline
Secondary	Assess the role of OCBs in predicting disease activity (conversion from CIS to MS)	measure positive predictive value and negative predictive value of oligoclonal bands	baseline