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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name