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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021679
Receipt No. R000025004
Scientific Title Detection of Diagnostic Biomarkers for Pediatric Rheumatic Diseases Using Proteomic Analysis
Date of disclosure of the study information 2016/06/01
Last modified on 2019/10/02

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Basic information
Public title Detection of Diagnostic Biomarkers for Pediatric Rheumatic Diseases Using Proteomic Analysis
Acronym Detection of Diagnostic Biomarkers for Pediatric Rheumatic Diseases
Scientific Title Detection of Diagnostic Biomarkers for Pediatric Rheumatic Diseases Using Proteomic Analysis
Scientific Title:Acronym Detection of Diagnostic Biomarkers for Pediatric Rheumatic Diseases
Region
Japan

Condition
Condition Pediatric Rheumatic Diseases (juvenile idiopathic arthritis(JIA), systemic lupus erythematosus(SLE), juvenile dermatomyositis(JDM), Sjogren syndrome(SS),etc)
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Now, the diagnosis of pediatric rheumatic diseases depend on their own clinical features. Therefore, diagnostic biomarkers for early diagnosis and therapy for pediatric rheumatic diseases are always 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 pediatric rheumatic diseases' 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
1 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria The subjects of this study were the patients with pediatric theumatic diseases aged 1 month to 20 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 active period before intervention. The recovery phase is defined as the stable period following intervention. We use the samples from the other illnesses aged from 0 to 20 years who were divided into group 1 (G1; viral infection), group 2 (G2; bacterial infection), and group 3 (G3; autoimmune disease beside colagen diseases), and healthy subjects aged 1 month to 20 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 200

Research contact person
Name of lead principal investigator
1st name Masaaki
Middle name
Last name Mori
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Lifecourse Clinical Immunology
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL +81-3-5803-4876
Email mori.phv@tmd.ac.jp

Public contact
Name of contact person
1st name Masaaki
Middle name
Last name Mori
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Lifecourse Clinical Immunology
Zip code 113-8519
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 Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Health Labour Sciences Research Grant

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel +81-3-5803-4876
Email mori.phv@tmd.ac.jp

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 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)、大阪医科大学(大阪府)、鹿児島大学(鹿児島県)、北海道大学(北海道)、千葉こども病院(千葉県)、日本医科大学(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 12 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 pediatric rheumatic diseases' 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 30 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025004

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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