UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016038 |
|---|---|
| Receipt number | R000018643 |
| Scientific Title | MicroRNA expression analysis in patients with IBD |
| Date of disclosure of the study information | 2014/12/23 |
| Last modified on | 2018/12/26 14:35:41 |
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Basic information
Public title
MicroRNA expression analysis in patients with IBD
Acronym
MicroRNA expression analysis in patients with IBD
Scientific Title
MicroRNA expression analysis in patients with IBD
Scientific Title:Acronym
MicroRNA expression analysis in patients with IBD
Region
| Japan |
Condition
Condition
Inflammatory bowel disease (Ulcerative colitis, Crohn disease)
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to determine whether microRNA expression was altered in patients with inflammatory bowel disease.
Basic objectives2
Others
Basic objectives -Others
Pathologic grasp
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Functions and profiles of microRNA in IBD become clear.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic biopsy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The IBD patient who planned endoscopy and biopsy.
The patient who agreed with this study.
Key exclusion criteria
The patient who did not agree with this study.
The patient who cannot perform biopsy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Kimura |
Organization
Yokohama City University Medical Center
Division name
Inflammatory Bowel Disease Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama JAPAN
TEL
045-261-5656
hkim@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Kimura |
Organization
Yokohama City University Medical Center
Division name
Inflammatory Bowel Disease Center
Zip code
Address
4-57, Urafune-cho, Minami-ku, Yokohama JAPAN
TEL
045-261-5656
Homepage URL
hkim@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
The institute of medical science
The university of Tokyo
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
横浜市立大学附属市民総合医療センター（神奈川県）
東京大学医科学研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Significant alteration in miRNA expression
in line with inflammatory bowel disease was evident in the mucosa from the pouchitis patients. Interleukin 17 receptor A may be involved in the pathogenesis of pouchitis through the downregulation of microRNA 192.
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
| 2011 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 18 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 18 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 18 | Day |
Other
Other related information
Inoue E, Hata K, Kimura H, Yamaguchi K, Nojima M, Endo I, Shinozaki M. Altered expression of microRNAs in patients with pouchitis after restorative proctocolectomy. Surg Today. 2017 Dec;47(12):1484-1491.
Management information
Registered date
| 2014 | Year | 12 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018643
