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Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03004794
Enrollment
1581
Registered
2016-12-29
Start date
2015-06-30
Completion date
2016-08-31
Last updated
2016-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* missing data that could not be obtained

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026