UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011540 |
|---|---|
| Receipt number | R000013145 |
| Scientific Title | A multicenter study to identify susceptibility genes of Kawasaki disease |
| Date of disclosure of the study information | 2013/10/02 |
| Last modified on | 2026/03/02 15:06:18 |
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Basic information
Public title
A multicenter study to identify susceptibility genes of Kawasaki disease
Acronym
A multicenter study to identify susceptibility genes of Kawasaki disease
Scientific Title
A multicenter study to identify susceptibility genes of Kawasaki disease
Scientific Title:Acronym
A multicenter study to identify susceptibility genes of Kawasaki disease
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify genes related to susceptibility and severity of Kawasaki disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Frequencies of genetic variations in terms of susceptibility and severity of Kawasaki disease
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients and their relatives who had a past history of Kawasaki disease and gave written informed consent.
Key exclusion criteria
Individuals who didn't consent to the study.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Onouchi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Public Health
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
0334160181
onouchi@src.riken.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Kobayash |
Organization
National Center for Child health and Development
Division name
Department of Management and Strategy
Zip code
Address
2-10-1, Okura, Setagaya, Tokyo
TEL
0304160181
Homepage URL
http://raise.umin.jp/jkdgc/
torukoba@nifty.com
Sponsor or person
Institute
Japan Kawasaki Disease Genome Consortium
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2010 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Japan Kawasaki Disease Genome Consortium has been established in collaboration with multiple institutions within Japan. The following principles shall guide its operation:
1. Joint Research Activities
Participating institutions of the Kawasaki Disease Genetic Consortium shall conduct joint research concerning the pathology, treatment, immunology, and genetics of Kawasaki disease. Specific details regarding individual research protocols, objectives, funding acquisition, and other concrete conditions shall be documented separately and agreed upon in writing.
2. Advancement of Research Planning
Participating institutions shall cooperate to deepen their knowledge of the epidemiology and genomics of Kawasaki disease, and to formulate new research plans aimed at more effectively predicting and preventing the onset and aggravation of the disease.
3. Mutual Cooperation and Synergy
Participating institutions shall strive to ensure that their respective areas of expertise are utilized in a complementary and mutually beneficial manner through collaborative efforts within the Consortium.
Management information
Registered date
| 2013 | Year | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013145
