Multiple SclerosisNCT03004794
Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort
An observational study of Multiple Sclerosis, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- medical records review
- How many people
- 1,581 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- All patients with suspecting multiple sclerosis attending 4 tertiary referral centers in Egypt
Who cannot join
- missing data that could not be obtained
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- medical records review
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical records reviewOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoked Potentials (measure latency in m.sec)
Number of patients with delayed latency of Evoked Potentials
Measured: 13 months (through study completion)
Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB)
Number of patients with elevated IgG index and OCB
Measured: 13 months (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatem Samir Shehata, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004794
- Sponsor's protocol ID
- RC4
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort
- ClinicalTrials.gov ID
- NCT03004794
- Acronym / sponsor ID
- RC4
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,581 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (1 listed)
- All patients with suspecting multiple sclerosis attending 4 tertiary referral centers in Egypt
Key exclusion criteria (1 listed)
- missing data that could not be obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical records review | Other | – |
Primary outcome
Evoked Potentials (measure latency in m.sec)
Time frame: 13 months (through study completion)
Number of patients with delayed latency of Evoked Potentials
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoked Potentials (measure latency in m.sec) (time frame: 13 months (through study completion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.