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OpenTrials
Completed

NCT Number: NCT03004794

Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • missing data that could not be obtained

Treatment and study plan

medical records review

Other

Primary outcomes

  1. Evoked Potentials (measure latency in m.sec)

    Time frame: 13 months (through study completion)

    Number of patients with delayed latency of Evoked Potentials

  2. Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB)

    Time frame: 13 months (through study completion)

    Number of patients with elevated IgG index and OCB

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2016
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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