UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023836 |
|---|---|
| Receipt number | R000027464 |
| Scientific Title | Comprehensive analysis of immune cells involved in the pathogenesis of neonatal and pediatric gastrointestinal disease |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2020/12/16 17:40:23 |
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Basic information
Public title
Comprehensive analysis of immune cells involved in the pathogenesis of neonatal and pediatric gastrointestinal disease
Acronym
Comprehensive analysis of immune cells of neonatal and pediatric gastrointestinal disease
Scientific Title
Comprehensive analysis of immune cells involved in the pathogenesis of neonatal and pediatric gastrointestinal disease
Scientific Title:Acronym
Comprehensive analysis of immune cells of neonatal and pediatric gastrointestinal disease
Region
| Japan |
Condition
Condition
All of neonatal and pediatric gastrointestinal disease which need to be resected
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To make new findings about pathogenesis of neonatal and pediatric gastrointestinal disease by comprehensive analysis of immune cells.
Basic objectives2
Others
Basic objectives -Others
new findings about pathogenesis of neonatal and pediatric gastrointestinal disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between pathogenesis of neonatal and pediatric gastrointestinal disease and findings of comprehensive analysis.
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.diseases targeted for this study
2.A written informed consent is obtained in this study
3.exception to exclusion criterion
Key exclusion criteria
no consent for this study before the operation
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yujiro |
| Middle name | |
| Last name | Tanaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of pediatric surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku,Nagoya, Japan
TEL
052-744-2959
ytanaka-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Oshima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of pediatric surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku,Nagoya, Japan
TEL
052-744-2959
Homepage URL
oshima_kazuo@hotmail.com
Sponsor or person
Institute
Department of pediatric surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute for genetic medicine, Hokkaido university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Bioethics Committee
Address
65 Tsurumai-cho, Showa-ku,Nagoya, Japan
Tel
052-744-2479
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
Suspended
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data analysis in progress
Management information
Registered date
| 2016 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027464
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| Registered date | File name |
| Research case data | |
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