Kawasaki DiseaseNCT03861130
Genetic Determinants of Kawasaki Disease
An observational study of Kawasaki Disease and Atypical Kawasaki Disease, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Kawasaki disease (KD) is an acute self-limited vasculitis of infancy and early childhood. Most patients recover without sequelae although the inflammatory process causes permanent damage to the coronary arteries in 20-25% of untreated children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kawasaki Disease, Atypical Kawasaki Disease
- How many people
- 1,379 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2013to 30 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children under the care of consultant in hospital for Kawasaki disease, families who are members of the UK Kawasaki Support Group
Who may be able to join
- Affected children will be recruited if the treating clinician has made a diagnosis of possible Kawasaki disease (even if they do not fulfil the criteria below for Kawasaki disease).
- The current standard diagnostic criteria for KD (Circulation 2001 103 335-336 doi: 10.1161/01.CIR 103.2.335) are:
- The presence of fever for at least five days plus four of the following criteria:
- Changes in the peripheral extremities Acute: erythema and oedema of hands and feet Convalescent: membranous desquamation of fingertips
- Polymorphous exanthema
- Bilateral painless bulbar conjunctival injection without exudate
Show all 9Show fewer
- Changes in lips and oral cavity: erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae
- Cervical lymphadenopathy (>1.5cm diameter), usually unilateral Patients meeting not all of these criteria may meet the criteria for atypical Kawasaki disease, ie. if they have fever and two or three of the above criteria and elevation of CRP or echocardiographic evidence of coronary artery dilatation.
- Parents of affected child must be biological parents.
Who cannot join
- children who do not have a diagnosis of possible Kawasaki disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Determinants of Kawasaki Disease for Susceptibility and Outcome
Kawasaki disease (KD) is an acute self-limited vasculitis of infancy and early childhood. Most patients recover without sequelae although the inflammatory process causes permanent damage to the coronary arteries in 20-25% of untreated children. An infectious aetiology is suspected, but the causative agent has not been identified. The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.
Read the detailed description
The problem to be addressed;
Kawasaki disease is now the most common cause of acquired heart disease in children in Japan and North America. Kawasaki disease arises when genetically predisposed children encounter an as yet unidentified infectious agent which may cause only mild illness or no illness at all in children without the genetic predisposition. Other children may suffer permanent damage to the coronary arteries. Identification of the genes involved will help to improve understanding of the disease, and the development of better treatments.
Objective
The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.
Design
The study will recruit nuclear families (affected child and their biological parents) through participating NHS hospitals or through the records of the UK Kawasaki Support Group.
Study size
400 affected children and both biological parents (i.e. 1200 participants)
Procedures
Informed consent using age appropriate patient/parent/guardian information sheets will be taken from parents (or from children aged 16 and over), assent will be taken from the child under the age of 16 (if appropriate). Children recruited during the acute illness; routine clinical and laboratory data and research samples (blood, urine, throat swab). Children recruited retrospectively; study questionnaire (completed by parents), saliva samples.Saliva samples from parents
- Conditions
- Kawasaki Disease, Atypical Kawasaki Disease
- Keywords
- Kawasaki Disease
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kawasaki disease | Kawasaki disease affected children | |
| parent of Kawasaki disease affected child | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Susceptibility of coronary artery aneurysms for Kawasaki patients
Identification of genes that are associated with susceptibility of coronary artery aneurysms
Measured: end date; 30 December 2022
Secondary outcomes (1)
Disease severity for Kawasaki patients
Identification of genes that are associated with disease severity
Measured: end date; 30 December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start25 Feb 2013
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, UK Kawasaki Support Group, Imperial College Healthcare NHS Trust, University Hospitals of North Midlands NHS Trust, Burton Hospitals NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, Shrewsbury and Telford Hospitals NHS Trust, East Suffolk and North Essex NHS Foundation Trust, New Cross Hospital, Darlington Memorial Hospital, Torbay Hospital, Peterborough City Hospital, University Hospitals Coventry and Warwickshire NHS Trust, University Hospital of North Tees, Cambridge University Hospitals NHS Foundation Trust, Royal Cornwall Hospitals Trust, Birmingham Children's Hospital, University Hospital Birmingham NHS Foundation Trust, Wye Valley NHS Trust, South Tees Hospitals NHS Foundation Trust, Leeds General Infirmary, Bradford Royal Infirmary, University Hospitals of Morecambe Bay NHS Trust, Calderdale and Huddersfield NHS Foundation Trust, St. Richard's Hospital, Pinderfields General Hospital, Worthing Hospital, Airedale General Hospital, Sheffield Children's NHS Foundation Trust, Northwick Park Hospital, West Middlesex Hospital, Royal Albert Edward Infirmary, Macclesfield District General Hospital, Royal Oldham Hospital, Stepping Hill Hospital, North Manchester General Hospital, Royal Bolton Hospital NHS Foundation Trust, Kingston Hospital NHS Trust, Tameside Hospital NHS Foundation Trust, East Surrey Hospital, St. George's Hospital, London, Royal Alexandra Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Professor M Levin, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861130
- Sponsor's protocol ID
- 13SM0678
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2019
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants of Kawasaki Disease for Susceptibility and Outcome
- ClinicalTrials.gov ID
- NCT03861130
- Acronym / sponsor ID
- 13SM0678
- Conditions
- Kawasaki Disease, Atypical Kawasaki Disease
- Keywords
- Kawasaki Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,379 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Great Ormond Street Hospital for Children NHS Foundation Trust, UK Kawasaki Support Group, Imperial College Healthcare NHS Trust, University Hospitals of North Midlands NHS Trust, Burton Hospitals NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, Shrewsbury and Telford Hospitals NHS Trust, East Suffolk and North Essex NHS Foundation Trust, New Cross Hospital, Darlington Memorial Hospital, Torbay Hospital, Peterborough City Hospital, University Hospitals Coventry and Warwickshire NHS Trust, University Hospital of North Tees, Cambridge University Hospitals NHS Foundation Trust, Royal Cornwall Hospitals Trust, Birmingham Children's Hospital, University Hospital Birmingham NHS Foundation Trust, Wye Valley NHS Trust, South Tees Hospitals NHS Foundation Trust, Leeds General Infirmary, Bradford Royal Infirmary, University Hospitals of Morecambe Bay NHS Trust, Calderdale and Huddersfield NHS Foundation Trust, St. Richard's Hospital, Pinderfields General Hospital, Worthing Hospital, Airedale General Hospital, Sheffield Children's NHS Foundation Trust, Northwick Park Hospital, West Middlesex Hospital, Royal Albert Edward Infirmary, Macclesfield District General Hospital, Royal Oldham Hospital, Stepping Hill Hospital, North Manchester General Hospital, Royal Bolton Hospital NHS Foundation Trust, Kingston Hospital NHS Trust, Tameside Hospital NHS Foundation Trust, East Surrey Hospital, St. George's Hospital, London, Royal Alexandra Children's Hospital
- Study start
- 25 Feb 2013 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 4 Mar 2019 (actual)
- 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.
Kawasaki disease (KD) is an acute self-limited vasculitis of infancy and early childhood. Most patients recover without sequelae although the inflammatory process causes permanent damage to the coronary arteries in 20-25% of untreated children. An infectious aetiology is suspected, but the causative agent has not been identified. The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.
Detailed description
The problem to be addressed;
Kawasaki disease is now the most common cause of acquired heart disease in children in Japan and North America. Kawasaki disease arises when genetically predisposed children encounter an as yet unidentified infectious agent which may cause only mild illness or no illness at all in children without the genetic predisposition. Other children may suffer permanent damage to the coronary arteries. Identification of the genes involved will help to improve understanding of the disease, and the development of better treatments.
Objective
The investigators aim to identify the genes underlying both susceptibility to Kawasaki disease, and the development of coronary artery aneurysms.
Design
The study will recruit nuclear families (affected child and their biological parents) through participating NHS hospitals or through the records of the UK Kawasaki Support Group.
Study size
400 affected children and both biological parents (i.e. 1200 participants)
Procedures
Informed consent using age appropriate patient/parent/guardian information sheets will be taken from parents (or from children aged 16 and over), assent will be taken from the child under the age of 16 (if appropriate). Children recruited during the acute illness; routine clinical and laboratory data and research samples (blood, urine, throat swab). Children recruited retrospectively; study questionnaire (completed by parents), saliva samples.Saliva samples from parents
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kawasaki disease | – | –Kawasaki disease affected children |
| parent of Kawasaki disease affected child | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children under the care of consultant in hospital for Kawasaki disease, families who are members of the UK Kawasaki Support Group
Key inclusion criteria (9 listed)
- Affected children will be recruited if the treating clinician has made a diagnosis of possible Kawasaki disease (even if they do not fulfil the criteria below for Kawasaki disease).
- The current standard diagnostic criteria for KD (Circulation 2001 103 335-336 doi: 10.1161/01.CIR 103.2.335) are:
- Changes in the peripheral extremities Acute: erythema and oedema of hands and feet Convalescent: membranous desquamation of fingertips
- Polymorphous exanthema
- Bilateral painless bulbar conjunctival injection without exudate
Key exclusion criteria (1 listed)
- children who do not have a diagnosis of possible Kawasaki disease
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
Susceptibility of coronary artery aneurysms for Kawasaki patients
Time frame: end date; 30 December 2022
Identification of genes that are associated with susceptibility of coronary artery aneurysms
1 secondary outcome
Disease severity for Kawasaki patients
Time frame: end date; 30 December 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Professor M Levin study chair
Imperial College London
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 Kawasaki Disease and Atypical Kawasaki Disease, run by Imperial College London 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 9 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: status not confirmed, as of the sponsor's last update on 17 Nov 2022. 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?
Results are not available in the source record.
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?
Susceptibility of coronary artery aneurysms for Kawasaki patients (time frame: end date; 30 December 2022). 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 17 Nov 2022.