UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study on Barrett's esophagus in Japan
Title of the study (Brief title)	Prospective cohort study on Barrett's esophagus in Japan
Region	Japan

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

Objectives
Narrative objectives1	To investigate the incidence of adenocarcinoma and risk factor for the development of cancer in patients with Barrett's esophagus
Basic objectives2	Others
Basic objectives -Others	incidence study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	development of the adenocarcinoma in 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	1. patients with endoscopically identified long segment (>3cm) Barrett's esophagus 2. patients with written informed concent
Key exclusion criteria	1. patients with a history of gastrectomy 2. patients who do not have an indication for endoscopy
Target sample size	500

Research contact person
Name of lead principal investigator	Yoshikazu Kinoshita
Organization	Shimane University Faculty of Medicine
Division name	Second department of Internal Medicine
Address	89-1, Enya-cho, Izumo, Shimane
TEL	0853-20-2190
Email	kinosita@med.shimane-u.ac.jp

Public contact
Name of contact person	Norihisa Ishimura
Organization	Shimane University Faculty of Medicine
Division name	Second department of Internal Medicine
Address	89-1, Enya-cho, Izumo, Shimane
TEL	0853-20-2190
Homepage URL
Email	ishimura@med.shimane-u.ac.jp

Sponsor
Institute	Japan Gastroenterological Endoscopy Society
Institute
Department

Funding Source
Organization	Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization	Other
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	2014 Year 12 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 12 Month 27 Day
Anticipated trial start date	2011 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://202.253.19.65/CRNET_LSBE/index.htm
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective cohort study

Management information
Registered date	2014 Year 12 Month 24 Day
Last modified on	2016 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018622