UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024444 |
|---|---|
| Receipt number | R000028137 |
| Scientific Title | Clinical characteristics of eosinophilic esophagitis and esophageal eosinophilia diagnosed at medical checkup clinic 'MedCity21' |
| Date of disclosure of the study information | 2016/10/17 |
| Last modified on | 2020/01/31 15:33:47 |
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Basic information
Public title
Clinical characteristics of eosinophilic esophagitis and esophageal eosinophilia diagnosed at medical checkup clinic 'MedCity21'
Acronym
Clinical characteristics of eosinophilic esophagitis at medical checkup clinic
Scientific Title
Clinical characteristics of eosinophilic esophagitis and esophageal eosinophilia diagnosed at medical checkup clinic 'MedCity21'
Scientific Title:Acronym
Clinical characteristics of eosinophilic esophagitis at medical checkup clinic
Region
| Japan |
Condition
Condition
Eosinophilic esophagitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim are an epidemiological investigation of eosinophilic esophagitis at medical checkup clinic in Japan and an assessment of risk factor of this disease retrospectively.
Basic objectives2
Others
Basic objectives -Others
Epidemiological investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of eosinophilic esophagitis and esophageal eosinophilia at medical checkup clinic
Key secondary outcomes
Risk factor of eosinophilic esophagitis and esophageal eosinophilia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical examinees who undergo esophagogastroduodenoscopy in private health screening program at medical checkup clinic 'MedCity21'
Key exclusion criteria
Examinees who are considered as inadequate by attending physician
Target sample size
9033
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | TANAKA |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
0666453811
m2079981@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | TANAKA |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
0666453811
Homepage URL
m2079981@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Review Board
Address
1-2-7, Asahimachi, Abeno-ku
Tel
06-6645-3435
ethics@med.osaka-cu.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
大阪市立大学医学部附属病院先端予防医療部附属クリニックMedCity21
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5964
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
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results of this study was published.
Management information
Registered date
| 2016 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028137
