UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014640 |
|---|---|
| Receipt number | R000017033 |
| Scientific Title | Investigation of Reflux Esophagitis - Identifying factors predicting future onset of reflux esophagitis by examining changes over time in health examination data - |
| Date of disclosure of the study information | 2014/07/24 |
| Last modified on | 2017/02/20 16:57:20 |
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Basic information
Public title
Investigation of Reflux Esophagitis
- Identifying factors predicting future onset of reflux esophagitis by examining changes over time in health examination data -
Acronym
Investigation to identify factors predicting future onset of reflux esophagitis based on health examination data
Scientific Title
Investigation of Reflux Esophagitis
- Identifying factors predicting future onset of reflux esophagitis by examining changes over time in health examination data -
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takashi Joh |
Organization
Nagoya City University
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL
052-853-8211
tjoh@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kubota |
Organization
Nagoya City University
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi 467-8601, Japan
TEL
052-853-8211
Homepage URL
ekubota@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Society for GERD
Institute
Department
Personal name
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)
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
| 2014 | Year | 07 | Month | 24 | 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
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
Main results already published
Date of protocol fixation
| 2013 | Year | 12 | Month | 03 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017033
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
