UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016396
Receipt number R000019043
Scientific Title Transcriptome analysis on the similarity between eosinophilic esophagitis and reflux esophagitis
Date of disclosure of the study information 2015/02/01
Last modified on 2018/03/28 15:29:15

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Basic information

Public title

Transcriptome analysis on the similarity between eosinophilic esophagitis and reflux esophagitis

Acronym

Transcriptome analysis on the similarity between eosinophilic esophagitis and reflux esophagitis

Scientific Title

Transcriptome analysis on the similarity between eosinophilic esophagitis and reflux esophagitis

Scientific Title:Acronym

Transcriptome analysis on the similarity between eosinophilic esophagitis and reflux esophagitis

Region

Japan


Condition

Condition

eosinophilic esophagitis, reflux esophagitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the pathologic overlap of eosinophilic esophagitis and reflux esophagitis by transcriptome analysis.

Basic objectives2

Others

Basic objectives -Others

To identify the pathologic similarity between eosinophilic esophagitis and reflux esophagitis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The comprehensive similarity of transcriptome profiling between eosinophilic esophagitis and reflux esophagitis

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with eosinophilic esophagitis or reflux esophagitis, who undergoes upper gastrointestinal endoscopy.
2. Patients with written informed consent.

Key exclusion criteria

1. Patients with anticoagulant therapy
2. Patients with other serious conditions
3. Others who are not eligible for participation judged by a doctor

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihisa Ishimura

Organization

Shimane University Faculty of Medicine

Division name

Department of Internal Medicine II

Zip code


Address

89-1, Enya-cho, Izumo, Shimane

TEL

0853-20-2190

Email

ishimura@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norihisa Ishimura

Organization

Shimane University Faculty of Medicine

Division name

Department of Internal Medicine II

Zip code


Address

89-1, Enya-cho, Izumo, Shimane

TEL

0853-20-2190

Homepage URL


Email

ishimura@med.shimane-u.ac.jp


Sponsor or person

Institute

Department of Internal Medicine II, Shimane University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Center for Child Health and Development; Center for Genomic Medicine, Kyoto University

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

島根大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 02 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

Terminated

Date of protocol fixation

2015 Year 01 Month 26 Day

Date of IRB


Anticipated trial start date

2015 Year 02 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

Prospective study


Management information

Registered date

2015 Year 01 Month 31 Day

Last modified on

2018 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019043


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name