UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023980 |
|---|---|
| Receipt number | R000027606 |
| Scientific Title | development of biomarkers for clarifying pathology and evaluating activity in pediatric immune-related diseases |
| Date of disclosure of the study information | 2016/09/08 |
| Last modified on | 2023/03/15 06:25:20 |
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Basic information
Public title
development of biomarkers for clarifying pathology and evaluating activity in pediatric immune-related diseases
Acronym
development of biomarkers for clarifying pathology and evaluating activity in pediatric immune-related diseases
Scientific Title
development of biomarkers for clarifying pathology and evaluating activity in pediatric immune-related diseases
Scientific Title:Acronym
development of biomarkers for clarifying pathology and evaluating activity in pediatric immune-related diseases
Region
| Japan |
Condition
Condition
pediatric immune-related diseases
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to develop biomarkers related disease state
Basic objectives2
Others
Basic objectives -Others
to elucidate disease state
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
development biomarkers to evaluating disease activity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) childhood-onset immune-related disease
2) witten informed consent
Key exclusion criteria
patients judged by the investigator to be unfit to participate in the study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Ito |
Organization
Yokohama city university
Division name
Department of Pediatrics
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2800
itoshu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Murase |
Organization
Yokohama city university
Division name
Department of Pediatrics
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL
045-787-2800
Homepage URL
t206076d@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Tokyo Metropolitan Children's Medical Center
Yokohama City University Medical Center
Yokohama Rosai Hospital
Yokosuka Kyosai Hospital
Yokohama Minami Kyosai Hospital
Saiseikai Yokohamashi Nanbu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
YCU Center for Novel and Exploratory Clinical Trials
Address
1-1-1 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
Tel
045-370-7933
ynext@yokohama-cu.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate chart about clinical data.
Management information
Registered date
| 2016 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027606
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
