UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008262 |
|---|---|
| Receipt number | R000009710 |
| Scientific Title | The analysis of inflammatory signals in Japanese children with inflammatory bowel disease |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2012/06/26 14:46:55 |
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Basic information
Public title
The analysis of inflammatory signals in Japanese children with inflammatory bowel disease
Acronym
Immune analysis in Japanese IBD children
Scientific Title
The analysis of inflammatory signals in Japanese children with inflammatory bowel disease
Scientific Title:Acronym
Immune analysis in Japanese IBD children
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find a pathogenesis of pediatric IBD, inflammatory signaling molecules were investigated in inflammued mucosa taken from Japanese IBD children.
Basic objectives2
Others
Basic objectives -Others
To find a pathogenesis of pediatric IBD, inflammatory signaling molecules were investigated using microarray, RT-PCR, and immunehistochemistry in inflammued mucosa taken from Japanese IBD children.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mechanism of IBD in children
Key secondary outcomes
Factors for severe inflammation
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
| 1 | years-old | <= |
Age-upper limit
| 17 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children who show bloody stool, including juvenile polyp, lymphoid hyperplasia, food allergy, ulcerative colitis, and Crohn's disease.
Key exclusion criteria
Children in life threatening state, children with bleeding tendency, children whose parents are refusing to precipitate, and children that doctors thinks there is a problem in endoscopic analysis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ohtsuka |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ohtsuka |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
yohtsuka@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
順天堂大学附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Expression of inflammatory signaling molecules in pediatric IBD patients.
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2012 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009710
