Characteristics and Outcomes of Childhood Moyamoya in the UK | NCT02434302

Studies
Characteristics and Outcomes of Childhood Moyamoya in the UK

NCT02434302

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

98Actual

Phase

Not provided

Conditions

Moyamoya

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

May 4, 2015

First Posted Date

May 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2021

Last Update Posted Date

Dec 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of children with moyamoya in UK		2 years

Secondary Outcomes

Measure	Description	Time Frame
clinical features & outcomes of childhood moyamoya		2 years
radioplogical features of childhood Moyamoya		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radiological diagnosis of moyamoya

Exclusion Criteria:

Refuse consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children (0-18y) with moyamoya in the UK over study period (2014-2016 August)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
vijeya ganesan, MB ChB MD	UCL Institute of Child Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Great Ormond Street Hospital for CHidlren NHS Foundation Trust		London		WC1N 3LU	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009072	Moyamoya Disease

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided