MoyamoyaNCT02434302
Characteristics and Outcomes of Childhood Moyamoya in the UK
An observational study of Moyamoya, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a study to ascertain the number of children with moyamoya in the UK, their presenting features, clinical course and outcomes. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Moyamoya
- How many people
- 98 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Dec 2015
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (0-18y) with moyamoya in the UK over study period (2014-2016 August)
Who may be able to join
- Radiological diagnosis of moyamoya
Who cannot join
- Refuse consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for CHidlren NHS Foundation Trust
London, WC1N 3LU
About this study
This is a study to ascertain the number of children with moyamoya in the UK, their presenting features, clinical course and outcomes.
Read the detailed description
The study ahs 3 components:
- Patient identification via the British Paediatric Surveillance Unit, and the 21 collaborating centres
- Record review/patient interview to determine clinical features \& outcomes
- Centralised review of imaging data to ascertain radiological phenotypes
- Conditions
- Moyamoya
- Medical subject headings
- Moyamoya Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with moyamoya in UK
Measured: 2 years
Secondary outcomes (2)
clinical features & outcomes of childhood moyamoya
Measured: 2 years
radioplogical features of childhood Moyamoya
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoyamoyaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- vijeya ganesan, MB ChB MD, Principal investigator, UCL Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434302
- Sponsor's protocol ID
- 13NR31
- Status last verified
- Dec 2021
- First submitted
- 30 Apr 2015
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Childhood Moyamoya in the UK
- ClinicalTrials.gov ID
- NCT02434302
- Acronym / sponsor ID
- 13NR31
- Conditions
- Moyamoya
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 May 2015 (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.
This is a study to ascertain the number of children with moyamoya in the UK, their presenting features, clinical course and outcomes.
Detailed description
The study ahs 3 components:
- Patient identification via the British Paediatric Surveillance Unit, and the 21 collaborating centres
- Record review/patient interview to determine clinical features \& outcomes
- Centralised review of imaging data to ascertain radiological phenotypes
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (0-18y) with moyamoya in the UK over study period (2014-2016 August)
Key inclusion criteria (1 listed)
- Radiological diagnosis of moyamoya
Key exclusion criteria (1 listed)
- Refuse consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of children with moyamoya in UK
Time frame: 2 years
2 secondary outcomes
clinical features & outcomes of childhood moyamoya
Time frame: 2 years
radioplogical features of childhood Moyamoya
Time frame: 2 years
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 2 Dec 2021.
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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.
vijeya ganesan, MB ChB MD principal investigator
UCL Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
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 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of children with moyamoya in UK (time frame: 2 years). 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 2 Dec 2021.