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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021329
Receipt No. R000024598
Scientific Title Detection of Diagnostic Biomarkers for Kawasaki Disease Using Proteomic Analysis
Date of disclosure of the study information 2016/03/04
Last modified on 2017/04/02

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Basic information
Public title Detection of Diagnostic Biomarkers for Kawasaki Disease Using Proteomic Analysis
Acronym Detection of Diagnostic Biomarkers for Kawasaki Disease
Scientific Title Detection of Diagnostic Biomarkers for Kawasaki Disease Using Proteomic Analysis
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaaki Mori
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Pharmacovigilance
Zip code
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
1st name
Middle name
Last name Masaaki Mori
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Pharmacovigilance
Zip code
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)

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 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

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 We have published this results in Scientic Reports.
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 Completed
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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