Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-11 @ 11:06 PM
Study NCT ID:
NCT03004794
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2016-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: