UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults
Title of the study (Brief title)	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	Toshiaki GUNJI
Organization	NTT Medical Center Tokyo
Division name	Center for Preventive Medicine
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	Toshiaki GUNJI
Organization	NTT Medical Center Tokyo
Division name	Center for Preventive Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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