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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004875
Receipt No. R000005794
Scientific Title Role of central obesity in Barrett's esophagus
Date of disclosure of the study information 2011/01/21
Last modified on 2013/03/11

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Basic information
Public title Role of central obesity in Barrett's esophagus
Acronym Role of central obesity in Barrett's esophagus
Scientific Title Role of central obesity in Barrett's esophagus
Scientific Title:Acronym Role of central obesity in Barrett's esophagus
Region
Japan

Condition
Condition Barrett's esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between central obesity and Barrett's esophagus
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of central obesity on Barrett's esophagus
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects undergoing health checkups including upper gastrointestinal endoscopy screening and computed tomography screening
Key exclusion criteria Cases under medication for reflux symptoms, peptic ulcer, and gastric/esophageal or other cancers are excluded from the study. Cases diagnosed as gastric or esophageal cancer at the time of endoscopy screening are also excluded from the study.
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki GUNJI
Organization Kanto Medical Center, NTT East Tokyo
Division name Center for Preventive Medicine
Zip code
Address 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanto Medical Center, NTT East Tokyo
Division name Center for Preventive Medicine
Zip code
Address 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo 141-8625, Japan.
TEL
Homepage URL
Email

Sponsor
Institute Kanto Medical Center, NTT East Tokyo
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2011 Year 01 Month 21 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 Completed
Date of protocol fixation
2010 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2011 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 Japanese subjects (males and females) who visit our institute for a comprehensive medical survey are enrolled. All subjects voluntarily participate in a self-paid health check-up program including blood test screening, physical examinations, and esophagogastroduodenoscopy. Visceral and subcutaneous adipose tissue are measured by computed tomography at the navel level. Independent and significant predictors of Barrett's esophagus are determined by multivariate analysis.

Management information
Registered date
2011 Year 01 Month 14 Day
Last modified on
2013 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005794

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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