UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014119 |
|---|---|
| Receipt number | R000016438 |
| Scientific Title | Study for new biomarker development for diagnosis and evaluation of disease activity in juvenile rheumatic disease |
| Date of disclosure of the study information | 2014/06/09 |
| Last modified on | 2021/06/15 11:58:04 |
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Basic information
Public title
Study for new biomarker development for diagnosis and evaluation of disease activity in juvenile rheumatic disease
Acronym
Biomarker for juvenile rheumatic disease
Scientific Title
Study for new biomarker development for diagnosis and evaluation of disease activity in juvenile rheumatic disease
Scientific Title:Acronym
Biomarker for juvenile rheumatic disease
Region
| Japan |
Condition
Condition
juvenile idiopathic arthritis, juvenile systemic erythematosus, juvenile dermatomyositis, juvenile Sjoegren syndrome, juvenile connective tissue disease, Henoch-Schonlein purpura, juvenile polyarteritis nodosa, juvenile aortitis syndrome, ulcerative colitis, Crohn's disease
Classification by specialty
| Clinical immunology | Pediatrics | Laboratory medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of PTX3 in assessment of remission or flare up of Pediatric rheumatic disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to establish significant parameters that help to distinguish remission from flare of diseases, and identify cut off values
Key secondary outcomes
PTX3 versus C-reactive protein
PTX3 versus sLOX-1
PTX3 versus disease activity
sLOX-1 versus disease activity
PTX3 with steroid dose
PTX3 with hospitalization
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric rheumatic disease patients
Key exclusion criteria
patient who did not fulfill the rheumatic disease criteria.
patients for whom data were insufficient.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kitoh |
Organization
Aichi Medical University Hospital
Division name
Pediatrics
Zip code
480-1195
Address
1-1 Yazako Karimata, Nagakute
TEL
0561-62-3311
tkitoh@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kitoh |
Organization
Aichi Medical University
Division name
Pediatrics
Zip code
4801195
Address
Department of Pediatrics
TEL
+81561623311
Homepage URL
tkitoh@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Non profit foundation Aichi Medical University "Aikei-Kai"
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pediatrics, Kanazawa University
Department of Pediatrics, Kyoto University Hospital
Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Kobe Gakuin University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical School
Address
1-1 Yazaka Karimata
Tel
+81561623311
tkitoh@aichi-med-u.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
聖隷浜松病院小児科（静岡県）Department of Pediatrics, Seirei Hamamatsu General Hospital(Shizuoka)
浜松医科大学小児科（静岡県）Department of Pediatrics, Hamamatsu University of Medicine (Shizuoka)
あいち小児保健医療総合センター感染免疫科（愛知県）Department of Infection and Immunology, Aichi Children's Health and Medical Center (Aichi)
岐阜大学大学院医学系研究科小児病態学（岐阜県）Department of Pediatrics, Graduate School of Medicine Gifu University (Gifu)
国立病院機構 三重病院小児科（三重県）Department of Pediatrics, National Mie Hospital (Mie)
金沢大学病院小児科（石川県）Department of Pediatrics, Kanazawa University Hospital (Ishikawa)
滋賀県立小児保健医療センター血液・リウマチ科（滋賀県）Department of Hematology/ Rheumatology, Shiga Medical Center for Children (Shiga)
京都大学医学部附属病院小児科（京都府） Department of Pediatrics, Kyoto University Hospital (Kyoto)
兵庫県立こども病院アレルギー・リウマチ科（兵庫県）Hyogo Children’s Hospital (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 09 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
IRB approoved
Management information
Registered date
| 2014 | Year | 05 | Month | 30 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016438
