UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	MicroRNA expression analysis in patients with IBD
Title of the study (Brief title)	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	Hideaki Kimura
Organization	Yokohama City University Medical Center
Division name	Inflammatory Bowel Disease Center
Address	4-57, Urafune-cho, Minami-ku, Yokohama JAPAN
TEL	045-261-5656
Email	hkim@yokohama-cu.ac.jp

Public contact
Name of contact person	Hideaki Kimura
Organization	Yokohama City University Medical Center
Division name	Inflammatory Bowel Disease Center
Address	4-57, Urafune-cho, Minami-ku, Yokohama JAPAN
TEL	045-261-5656
Homepage URL
Email	hkim@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018643