Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03360188 |
| Other study ID # |
POMS1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
November 28, 2017 |
| Last updated |
December 1, 2017 |
| Start date |
June 2011 |
| Est. completion date |
December 2015 |
Study information
| Verified date |
December 2017 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A medical record review of historic and current information on 237 patients attending 5
tertiary referral centers [Kasr Al-Ainy Multiple Sclerosis Research Unit (KAMSU) - Cairo
University Hospitals, Abo El Reesh Pediatric Hospital and 3 private centers] in Cairo, Egypt
from period between 2011 and December 2015.
Initially, medical records of 251 patients with the first acquired demyelinating events
started before age of 18 years were reviewed. Fourteen patients (5.58%) were excluded due to
missing data that could not be obtained.
Description:
The International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria were applied on
all included patients who were stratified into the following groups: (1) those with 2 or more
non-encephalopathic clinical CNS events (NEE) separated by > 30 days and involving > one area
of the CNS; (2) one non-encephalopathic episode typical of MS which is associated with MRI
findings consistent with 2010 Revised McDonald criteria for dissemination in space and in
which a follow up MRI shows at least one new enhancing or non-enhancing lesion consistent
with dissemination in time MS criteria; (3) one acute disseminated encephalomyelitis (ADEM)
attack followed by a non-encephalopathic clinical event, 3 or more months after symptom
onset, that is associated with new MRI lesions fulfilling 2010 Revised McDonald DIS criteria;
or (4) a first, single, acute event that does not meet ADEM criteria and whose MRI findings
are consistent with the 2010 Revised McDonald criteria for DIS and DIT (applies only to
children ≥12 years old).
These criteria were applied retrospectively in patients diagnosed before 2013. Procedures All
medical records were analyzed from June 2016 till April 2017 to collect the following data;
(1) demographic characteristics; (2) clinical data including age at first symptoms, age at
diagnosis, disease course, time to conversion to secondary progressive (SP) course, duration
of follow-up, initial and last Expanded Disability Status Scale (EDSS) score, time to (EDSS)
score of 4, family history of MS, disease-modifying treatments (DMTs), number of relapses in
the first year and the annualized relapse rate (ARR); (3) laboratorial data: oligoclonal
bands in the cerebrospinal fluid (CSF) and IgG index; (4) characteristics of the initial
magnetic resonance imaging (MRI) of the brain and spinal cord including: typicality of
lesions on T2 weighted sequence, presence of brain black holes in T1 weighted sequence,
presence of spinal cord T2 lesions, presence of gadolinium (Gd) enhancing lesions,
distribution of brain lesions (supratentorial and/or infratentorial).
Data quality. To ensure high-quality data, the accuracy and completeness were systemically
assessed. The medical records, administrative data, laboratory and diagnostic tests reports
were screened independently by 2 authors (NS and AE) and relevant data was extracted to a
standard electronic form according to KAMSU registry. An assigned coordinator from each
center was requested to facilitate data collection from site-specific records; an audit
site-specific data abstractor was continuously monitoring the records. Data accuracy was
checked by separate investigators (MA, HS, AH) who reviewed the electronic forms for
resemblance. Scheduled monthly meetings between abstractors were held to resolve any data
conflicts. In case of incomplete documentation or unclear information, verification was done
by the on-site data coordinator either by phone or during a face-to-face interview with the
patients or caregivers during routine follow up or unscheduled visits.
