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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023664
Receipt No. R000027256
Scientific Title The frequency of primary immunodeficiency in pediatric patiens with inflammatory bowel disease
Date of disclosure of the study information 2016/08/18
Last modified on 2019/03/06

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Basic information
Public title The frequency of primary immunodeficiency in pediatric patiens with inflammatory bowel disease
Acronym The frequency of primary immunodeficiency in pediatric patiens with inflammatory bowel disease
Scientific Title The frequency of primary immunodeficiency in pediatric patiens with inflammatory bowel disease
Scientific Title:Acronym The frequency of primary immunodeficiency in pediatric patiens with inflammatory bowel disease
Region
Japan

Condition
Condition inflammatory bowel disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 to analyse the frequency of primary immunodeficiency in pediatric patients with inflammatory bowel disease
Basic objectives2 Others
Basic objectives -Others to analyse the clinical features of primary immunodeficiency with inflammatory bowel disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the frequency of primary immunodeficiency in pediatric patients with inflammatory bowel disease
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 inflammatory bowel disease
2) written informed consent
Key exclusion criteria patients judged by the investigator to be unfit to participate in the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryosuke Kajiwara
Organization Yokohama city university
Division name Department of Pediatrics
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL 045-787-2800
Email t156015g@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi ohya
Organization Yokohama city university
Division name Department of Pediatrics
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email t156015g@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine, Department of Pediatrics
Institute
Department

Funding Source
Organization Yokohama City University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 08 Month 18 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
In this study, we found a WAS in three children with IBD. 
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 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 15 Day

Other
Other related information We investigate chart about clinical data.

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027256

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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