UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long term surveillance of Barrett's esophagus.
Title of the study (Brief title)	Long term surveillance of Barrett's esophagus.
Region	Japan

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

Objectives
Narrative objectives1	Risk factor of long Barrett's esophagus
Basic objectives2	Others
Basic objectives -Others	risk factor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Elongation 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Barrett's esophagus patients who have longer than 1cm
Key exclusion criteria	gastrectomy
Target sample size	500

Research contact person
Name of lead principal investigator	Noriaki Manabe
Organization	Kawasaki Medical School
Division name	clinical pathology and laboratory medicine
Address	577, Matsushima, Kurashiki, Okayama
TEL
Email

Public contact
Name of contact person
Organization	Kawasaki Medical School
Division name	clinical pathology and laboratory medicine
Address
TEL
Homepage URL
Email

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
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	2009 Year 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 16 Day
Anticipated trial start date	2009 Year 09 Month 17 Day
Last follow-up date	2014 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective cohrot study

Management information
Registered date	2009 Year 09 Month 16 Day
Last modified on	2018 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003068