Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT03004794
• Lead Sponsor: Cairo University

Brief Summary

Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the McDonald criteria.

Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient in different centers were counted only once.

Detailed Description

Patients' records review procedure and sampling strategies. The medical records, administrative data, laboratory and diagnostic tests reports were screened by 3 authors (HS, NS, AE) and these data were extracted in a standard electronic form according to Kasr Alaini Multiple Sclerosis Unit (KAMSU) registry.

An assigned coordinator from each center was requested to facilitate data collection from site-specific records. In cases of incomplete documentation or unclear information, verification was done by on-site data coordinator either by phone contact or face-to-face interview with the patients, whether during the routine follow up or in an unscheduled visit.

Several measures were taken to ensure the confidentiality of the collected information. No patient names were included in the database presented by site coordinator, and the study staff signed a confidentiality agreement for non-disclosure.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-12
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-23
• Last Update Submitted: 2016-12-23
• Study First Posted: 2016-12-29
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1581

Inclusion Criteria

• All patients with suspecting multiple sclerosis attending 4 tertiary referral centers in Egypt

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Exclusion Criteria

• missing data that could not be obtained

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB)	13 months (through study completion)	Number of patients with elevated IgG index and OCB
Evoked Potentials (measure latency in m.sec)	13 months (through study completion)	Number of patients with delayed latency of Evoked Potentials