UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Prospective Cohort Study on the usefulness of Kawasaki disease relevant proteins for diagnosis, treatment efficacy, and risk of coronary artery complications
Title of the study (Brief title)	A Prospective Cohort Study on the usefulness of Kawasaki disease relevant proteins for diagnosis, treatment efficacy, and risk of coronary artery complications.
Region	Japan

Condition
Condition	Subjects with fever
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of Kawasaki disease relevant proteins (LBP, LRG1, AGT, and RBP4) for diagnosis, treatment efficacy, and risk of coronary artery complications
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	o assess whether the addition of these proteins values concurrently with clinical diagnostic criteria is more effective than clinical diagnostic criteria alone, in the Kawasaki disease diagnosis setting
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	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects with two or more symptoms of clinical criteria for Kawasaki disease. Fever is essential symptom for inclusion to this study. 2. If Subjects have CALs, Subjects with one or more symptoms of Kawasaki disease clinical criteria including fever. 3. Subjects who have provided written informed consent by their guardians for participation in this study.
Key exclusion criteria	1. Subjects who could not be diagnosed for Kawasaki disease or not by their medical record and clinical course. 2.Applicable for the following criteria 1) Collagen disease such as juvenile idiopathic arthritis 2) Autoinflammatory syndrome, such as Cryopirin-associated periodic syndrome 3) On systemic administration of immunosuppressant or steroid, except for inhaled steroid therapy and anti-allergic medicine 3. Subjects who are judged as unsuitable for this study by physician
Target sample size	800

Research contact person
Name of lead principal investigator	Mori Masaaki
Organization	Medical Hospital, Tokyo Medical and Dental University
Division name	Department of Lifetime Clinical Immunology
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5803-5249
Email	mori.phv@tmd.ac.jp

Public contact
Name of contact person	Masakatsu Yanagimachi
Organization	Tokyo Medical and Dental University
Division name	Department of Pediatrics
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5803-5249
Homepage URL
Email	myanagimachi.ped@tmd.ac.jp

Sponsor
Institute	Medical Hospital, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Donations for Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
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	東京医科歯科大学医学部附属病院（東京都） 横浜市立大学先端医科学研究センター（神奈川県） 公立昭和病院（東京都） 東京北医療センター（東京都） 土浦協同病院（茨城県） 武蔵野赤十字病院（東京都） 川口市立医療センター（埼玉県） 国立福山医療センター（広島県） 済生会横浜市東部病院（神奈川県） 済生会横浜市南部病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 05 Month 18 Day
Anticipated trial start date	2017 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To evaluate the usefulness of Kawasaki disease relevant proteins (LBP, LRG1, AGT, and RBP4) for diagnosis, treatment efficacy, and risk of coronary artery complications.

Management information
Registered date	2017 Year 07 Month 23 Day
Last modified on	2017 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031909