UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030748 |
|---|---|
| Receipt number | R000033966 |
| Scientific Title | The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/09/03 16:08:51 |
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Basic information
Public title
The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults
Acronym
Risk factors for Barrett's esophagus
Scientific Title
The risk factors for Barrett's esophagus: A retrospective longitudinal study of an asymptomatic Japanese adults
Scientific Title:Acronym
Risk factors for Barrett's esophagus
Region
| Japan |
Condition
Condition
Barrett's esophagus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the risk factors for Barrett's esophagus in a longitudinal cohort study.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The impact of various factors, including life style factors, Helicobacter pylori, and central obesity, on the incidence 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We conducted a retrospective longitudinal study of a large number of Japanese adults, who underwent screening endoscopy twice (first endoscopy between 2007 and 2011 and second endoscopy between 2012 and 2016; mean interval was 60 months). All subjects visited our institute for participating in a comprehensive health-checkup program, including VAT/SAT evaluation by CT.
Key exclusion criteria
Subjects taking medications for gastroesophageal reflux symptoms, gastric/duodenal ulcers, or malignant diseases were excluded from the study. Subjects diagnosed as Barrett's esophagus or gastric/esophageal cancer at the time of first endoscopy were also excluded.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki GUNJI |
Organization
NTT Medical Center Tokyo
Division name
Center for Preventive Medicine
Zip code
Address
higashigotanda 5-9-22, shinagawa-ku, Tokyo, Japan
TEL
03-3448-6275
tgunji-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki GUNJI |
Organization
NTT Medical Center Tokyo
Division name
Center for Preventive Medicine
Zip code
Address
higashigotanda 5-9-22, shinagawa-ku, Tokyo, Japan
TEL
03-3448-6275
Homepage URL
tgunji-tky@umin.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
NTT
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 02 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 01 | Day |
Other
Other related information
The final results will be open on academic paper.
Management information
Registered date
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033966
