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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000937
Receipt No. R000001012
Scientific Title Molecular and endoscopic surveillance of Barrett's esophagus
Date of disclosure of the study information 2007/12/07
Last modified on 2013/06/15

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Basic information
Public title Molecular and endoscopic surveillance of Barrett's esophagus
Acronym Molecular and endoscopic surveillance of Barrett's esophagus
Scientific Title Molecular and endoscopic surveillance of Barrett's esophagus
Scientific Title:Acronym Molecular and endoscopic surveillance of Barrett's esophagus
Region
Japan

Condition
Condition Reflux esophagitis,Barrett's esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Aim of this study is to determine the pathogenesis of reflux esophagitis and Barrett's esophagus and to examine risk factor of the development to the esophageal adenocarcinoma.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Relasion between carcinogenesis of the esophageal adenocarcinoma from Barrett's esophagus and DNA methylation, a change of microRNA expression, oxidation stress marker,metabolic marker.
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 Eligibility criteria is the following.
1.Patient who have atended a Keio University Hospital
2.Patient who have Reflux esophagitis or Barrett's epithelium or Barrett's esophagus
3.Patient who provide weitten informed consent
Key exclusion criteria Exclusion criteria is the following.
1.Patient who have medical history of an upper gastrointestinal tract disease
2.Patient who have other severe diseases
3.Patient who take some anticoagulant or antiplatelet drugs and who cannnot stop it.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Suzuki, M.D., Ph.D.
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Suzuki
Organization Keio University
Division name Division of Gastroenterology,Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email hsuzuki@sc.itc.keio.ac.jp

Sponsor
Institute Division of Gastroenterology,Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2007 Year 12 Month 07 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
2007 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded
2012 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 07 Day
Last modified on
2013 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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