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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022504
Receipt No. R000025925
Scientific Title A cohort study of prevalence and natural history of upper gastrointestinal disease in the Japanese population --- a multi-center study ---
Date of disclosure of the study information 2016/06/02
Last modified on 2020/10/05

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Basic information
Public title A cohort study of prevalence and natural history of upper gastrointestinal disease in the Japanese population --- a multi-center study ---
Acronym UGID cohort study
Scientific Title A cohort study of prevalence and natural history of upper gastrointestinal disease in the Japanese population --- a multi-center study ---
Scientific Title:Acronym UGID cohort study
Region
Japan

Condition
Condition upper gastrointestinal disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to clarify the changes of clinical parameters associated with GERD and Functional Dyspepsia during 5 years follow-up period in the subjects who undergo health checkup
Basic objectives2 Others
Basic objectives -Others to clarify the prevalence of GERD and FD, and to clarify the natural history of GERD and FD.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. prevalence of GERD and FD at the registration.
2. prevalence of GERD and FD at the end of the observation period.
3. incidence, exacerbation rates, and remission rates of GERD and FD in the observation period.
Key secondary outcomes 1. factors associated with prevalence of GERD and FD at the registration.
2. factors associated with natural history of GERD and FD.
3. incidence of esophageal cancer and gastric cancer in the observation period.
4. association between eradication of Helicobacter pylori and incidence of upper gastrointestinal tract diseases

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. subjects who undergo health checkup including upper gastrointestinal endoscopy
2. more than 20 years old
Key exclusion criteria subjects who are judged as unsuitable for this study by the investigators
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name Yuzo
Middle name
Last name Kodama
Organization Kobe University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code 650-0017
Address Kusunoki-cho 7-1-5 Cuo-ku, Kobe 650-0017, Japan
TEL 078-382-6305
Email gcare@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Fujita
Organization Yodogawa Christian Hospital
Division name Health Care and Promotion Center
Zip code 533-0024
Address 1-7-50 Kunijima, Higashiyodogawa-ku, Osaka 533-0024, Japan
TEL 06(6322)2250
Homepage URL http://www.med.kobe-u.ac.jp/gicare/
Email gcare@med.kobe-u.ac.jp

Sponsor
Institute UGID Study Group
Institute
Department

Funding Source
Organization National University Corporation, Kobe University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Gastro-Intestinal Medicare Research and Education Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kobe University Hospital
Address Kusunoki-cho 7-1-5 Cuo-ku, Kobe 650-0017, Japan
Tel 0783826609
Email kansatsu@med.kobe-u.ac.jp

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 京都第二赤十字病院(京都府)、加古川中央市民病院(兵庫県)、北播磨総合医療センター(兵庫県)、福井赤十字病院(福井県)、大阪府済生会中津病院(大阪府)、ホテルオークラ神戸クリニック(兵庫県)、淀川キリスト教病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 8888
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 No longer recruiting
Date of protocol fixation
2012 Year 11 Month 22 Day
Date of IRB
2013 Year 04 Month 05 Day
Anticipated trial start date
2013 Year 05 Month 20 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information The baseline data were collected from a prospective, multicenter, cohort study in which Japanese subjects who underwent the upper endoscopy for health screening. 8883 subjects were enrolled. and prevalence and risk factors associated with erosive GERD (EE), non-erosive GERD (NERD) and functional dyspepsia (FD) were analyzed.
1. Erosive GERD (EE) was observed in 1418 subjects (16.1%), and severe symptomatic EE, mild symptomatic EE, and asymptomatic EE were 16.7%, 36.9%, and 67.4%, respectively. Symptomatic EE was more frequently overlapped with FD, and were associated with strong stress, anxiety, atrophic gastritis and use of PPI, compared with mild and asymptomatic EE.
2. NERD was observed in 504 subjects (5.7%). NERD subjects more took anti-acid secretory agents, and were associated with the factors related to the psychologic stress. One third of NERD subjects were overlapped with FD. NERD-FD overlapped subjects were common in female, and had more severe reflux symptoms.
3. FD was observed in 399 subjects (4.5%), and the half of FD subjects were overlapped with NERD. Compared with asymptomatic subjects without organic lesions, the FD-NERD plus the FD-alone subjects were more often took gastroprotective agents, and were associated with the psychologic stress, kyophosis, low BMI and less ARB.

Management information
Registered date
2016 Year 05 Month 27 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025925

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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