UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021679 |
|---|---|
| Receipt number | 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 | 2023/04/05 09:36:27 |
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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
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
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
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
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
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2026 | 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
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025004
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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