Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372977
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-30
Brief Title:
Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of Multiple Sclerosis and Prediction of Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Multiple sclerosis is a chronic inflammatory immune-mediated disorder of the central nervous systemDiagnosis 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 automatedrater 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None