UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of Reflux Esophagitis - Identifying factors predicting future onset of reflux esophagitis by examining changes over time in health examination data -
Title of the study (Brief title)	Investigation to identify factors predicting future onset of reflux esophagitis based on health examination data
Region	Japan

Condition
Condition	Reflux Esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary objective is to determine factors for predicting future RE onset using health examination data and changes in these data over time determined by reviewing the examination data over the past 5 years of patients newly diagnosed with RE in a health examination (hereafter called "new RE patients") and comparing the data to the examination data over the past 5 years of a control population matched with the new RE patients in terms of sex, age, timing of testing, and institution.
Basic objectives2	Others
Basic objectives -Others	Factors for predicting future RE onset
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Differences in changes over time in the primary survey parameters between the patient group and control group over the 5-year period preceding RE diagnosis. 2) Differences in the values of the primary survey parameters at each time point between the patient group and control group at the time of RE diagnosis and over the 5-year period preceding RE diagnosis.
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Case group: Patients aged >=30 with observation of RE onset based on endoscopic examination in health examination held from fiscal 2009 to fiscal 2013 Control group: Recipients aged >=30 with no history of RE on records of health examination held from fiscal 2004 to fiscal 2013
Key exclusion criteria	1) Patients or Recipients who do not take health examination held at least 3 fiscal years among the 5 fiscal years just before RE onset 2) Patients or Recipients who have undergone gastrointestinal resection or vagotomy
Target sample size	1800

Research contact person
Name of lead principal investigator	Takashi Joh
Organization	Nagoya City University
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL	052-853-8211
Email	tjoh@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Eiji Kubota
Organization	Nagoya City University
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL	052-853-8211
Homepage URL
Email	ekubota@med.nagoya-cu.ac.jp

Sponsor
Institute	Society for GERD
Institute
Department

Funding Source
Organization	AstraZeneca K.K.
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	2014 Year 07 Month 24 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 12 Month 03 Day
Anticipated trial start date	2014 Year 06 Month 18 Day
Last follow-up date	2015 Year 01 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The primary objective is to determine factors for predicting future RE onset using health examination data and changes in these data over time determined by reviewing the examination data over the past 5 years of patients newly diagnosed with RE in a health examination (hereafter called "new RE patients") and comparing the data to the examination data over the past 5 years of a control population matched with the new RE patients in terms of sex, age, timing of testing, and institution.

Management information
Registered date	2014 Year 07 Month 24 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017033