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

NCT06372977 | Not Yet Recruiting

• 1 other identifier: kappa index in ms
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

To:

1. 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. 2.Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis)

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Assess the role of k FLC in predicting disease activity (conversion from CIS to MS)

  baseline

• Assess the role of OCBs in predicting disease activity (conversion from CIS to MS)

  baseline

Study Arms (2)

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 )

Diagnostic Test: kappa index

2

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

Diagnostic Test: kappa index

Interventions

kappa index DIAGNOSTIC_TEST

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

1; 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

we will select for this study 140 patients including control group and patients group aged between 18 -40

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 31743879 BACKGROUND

• 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.

  PMID: 32527760 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

reham abdelsater, assistant lecturer

CONTACT

01024478076; rehamabdelsater@gmail.com

Madeha Younis bakheet, professor

CONTACT

01009344150; m.younis@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-03