UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028340
Receipt No. R000031909
Scientific Title A Prospective Cohort Study on the usefulness of Kawasaki disease relevant proteins for diagnosis, treatment efficacy, and risk of coronary artery complications
Date of disclosure of the study information 2017/07/24
Last modified on 2017/07/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.