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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023836
Receipt No. 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 2017/08/31

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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
Middle name
Last name Yujiro Tanaka
Organization Nagoya University Graduate School of Medicine
Division name Department of pediatric surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku,Nagoya, Japan
TEL 052-744-2959
Email tanakayujiro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Oshima
Organization Nagoya University Graduate School of Medicine
Division name Department of pediatric surgery
Zip code
Address 65 Tsurumai-cho, Showa-ku,Nagoya, Japan
TEL 052-744-2959
Homepage URL
Email k-oshima@med.nagoya-u.ac.jp

Sponsor
Institute Department of pediatric surgery, Nagoya University Graduate School of Medicine
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information data collecting

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2017 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027464

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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