Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

December 23, 2016 updated by: Hatem Samir Shehata, Cairo University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the McDonald criteria, and patients were classified according to the course of the disease into relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) and primary-progressive multiple sclerosis (PPMS). Patients with first demyelinating event, before 2010, were re-assessed by on-site coordinators to label them clinically isolated syndrome (CIS), whenever applicable, according to McDonalds 2010, and neuromyelitis optica (NMO) cases diagnosis was verified according to the 2015 diagnostic criteria. Those with typical brain Magnetic Resonant Imaging (MRI) MS like lesions without related clinical manifestations were diagnosed as radiologically isolated syndrome (RIS).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • missing data that could not be obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evoked Potentials (measure latency in m.sec)
Time Frame: 13 months (through study completion)
Number of patients with delayed latency of Evoked Potentials
13 months (through study completion)
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
13 months (through study completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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