An observational study in Multiple Sclerosis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Assiut University · Observational
To:
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
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 1,034 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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we will select for this study 140 patients including control group and patients group aged between 18 -40
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Exclusion Criteria:
(-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
(+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
CSF albumin /serum albumin ratio (Qalb) k-index = (CSF kFLC/serum kFLC)/Qalb
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
Time frame: 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
Time frame: baseline
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
Time frame: baseline
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
Time frame: baseline
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This study is status unknown, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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