UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021329
Receipt number 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 19:01:28

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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 or person

Institute

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Institute

Department

Personal name



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

Value
https://center6.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