UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of Diagnostic Biomarkers for Kawasaki Disease Using Proteomic Analysis
Title of the study (Brief title)	Detection of Diagnostic Biomarkers for Kawasaki Disease
Region	Japan

Condition
Condition	Kawasaki disease
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Now, the diagnosis of KD depends on its clinical features. Therefore, diagnostic biomarkers for diagnosing Kawasaki disease are being sought
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To find the biomarkers used to establish a new diagnostic method for elucidating KD pathogenesis potentially
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	0 years-old <=
Age-upper limit	10 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects of this study were the patients with KD aged 1 month to 10 years in the acute phase and the recovery phase. The diagnosis of KD was performed according to clinical criteria. The acute phase is defined as the febrile period before intervention. The recovery phase is defined as the afebrile period following intervention. We use the samples from the other illnesses aged from 0 to 10 years who were divided into group 1 (G1; viral infection), group 2 (G2; bacterial infection), and group 3 (G3; autoimmune disease), and healthy subjects aged 1 month to 10 years served as a control group.
Key exclusion criteria	The child who is not obtained the consent by a parent or the person in the groups mentioned above
Target sample size	50

Research contact person
Name of lead principal investigator	Masaaki Mori
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Pharmacovigilance
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	+81-3-5803-4876
Email	mori.phv@tmd.ac.jp

Public contact
Name of contact person	Masaaki Mori
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Pharmacovigilance
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	+81-3-5803-4876
Homepage URL
Email	mori.phv@tmd.ac.jp

Sponsor
Institute	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	the Special Coordination Fund for Promoting Science and Technology, Creation and Innovation Centers for Advanced Interdisciplinary Research Areas
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	公立昭和病院（東京都）、横浜市立大学附属病院・附属市民総合医療センター・先端医療研究センター（神奈川県）、神奈川こども医療センター（神奈川県）、神戸大学病院（兵庫県）、国立福山医療センター（広島県）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We have published this results in Scientic Reports.
Other related information	In order to comprehensively compare the serum proteins during the acute and recovery phases from KD patients, we performed proteomic analysis using mass spectrometry (MS). We subsequently validated candidate KD protein biomarkers by western blot analysis and ELISA microarray technology. And, we collected new patients' sera, so we will confirm plasticity from now.

Management information
Registered date	2016 Year 03 Month 04 Day
Last modified on	2017 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024598