UMIN-CTR Clinical Trial

Public title

A Prospective Cohort Study on the usefulness of Kawasaki disease relevant proteins for diagnosis, treatment efficacy, and risk of coronary artery complications

Acronym

A Prospective Cohort Study on the usefulness of Kawasaki disease relevant proteins for diagnosis, treatment efficacy, and risk of coronary artery complications.

Scientific Title

A Prospective Cohort Study on the usefulness of Kawasaki disease relevant proteins for diagnosis, treatment efficacy, and risk of coronary artery complications

Scientific Title:Acronym

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

Subjects with fever

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Mori Masaaki

Organization

Medical Hospital, Tokyo Medical and Dental University

Division name

Department of Lifetime Clinical Immunology

Zip code

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5803-5249

Email

mori.phv@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Masakatsu Yanagimachi

Organization

Tokyo Medical and Dental University

Division name

Department of Pediatrics

Zip code

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5803-5249

Homepage URL

Email

myanagimachi.ped@tmd.ac.jp

Institute

Medical Hospital, Tokyo Medical and Dental University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

07

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017

Year

05

Month

18

Day

Date of IRB

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

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.

Registered date

2017

Year

07

Month

23

Day

Last modified on

2017

Year

07

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031909