UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022504 |
|---|---|
| Receipt number | 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 | 2023/06/02 19:08:38 |
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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
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/
gcare@med.kobe-u.ac.jp
Sponsor or person
Institute
UGID Study Group
Institute
Department
Personal name
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
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
| 2026 | 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
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025925
