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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030748
Receipt No. R000033966
Scientific Title The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults
Date of disclosure of the study information 2018/03/01
Last modified on 2018/09/03

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Basic information
Public title The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults
Acronym Risk factors for Barrett's esophagus
Scientific Title The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults
Scientific Title:Acronym Risk factors for 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 risk factors for Barrett's esophagus in a longitudinal cohort study.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The impact of various factors, including life style factors, Helicobacter pylori, and central obesity, on the incidence of 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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We conducted a retrospective longitudinal study of a large number of Japanese adults, who underwent screening endoscopy twice (first endoscopy between 2007 and 2011 and second endoscopy between 2012 and 2016; mean interval was 60 months). All subjects visited our institute for participating in a comprehensive health-checkup program, including VAT/SAT evaluation by CT.
Key exclusion criteria Subjects taking medications for gastroesophageal reflux symptoms, gastric/duodenal ulcers, or malignant diseases were excluded from the study. Subjects diagnosed as Barrett's esophagus or gastric/esophageal cancer at the time of first endoscopy were also excluded.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki GUNJI
Organization NTT Medical Center Tokyo
Division name Center for Preventive Medicine
Zip code
Address higashigotanda 5-9-22, shinagawa-ku, Tokyo, Japan
TEL 03-3448-6275
Email tgunji-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki GUNJI
Organization NTT Medical Center Tokyo
Division name Center for Preventive Medicine
Zip code
Address higashigotanda 5-9-22, shinagawa-ku, Tokyo, Japan
TEL 03-3448-6275
Homepage URL
Email tgunji-tky@umin.ac.jp

Sponsor
Institute NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization NTT
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 03 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 Completed
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2018 Year 09 Month 02 Day
Date of closure to data entry
2018 Year 09 Month 02 Day
Date trial data considered complete
2018 Year 09 Month 02 Day
Date analysis concluded
2018 Year 10 Month 01 Day

Other
Other related information The final results will be open on academic paper.

Management information
Registered date
2018 Year 01 Month 10 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033966

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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