UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016093 |
|---|---|
| Receipt number | R000018690 |
| Scientific Title | Establishment of nationwide database related to gastroenterological endoscopy |
| Date of disclosure of the study information | 2014/12/31 |
| Last modified on | 2023/07/11 14:36:21 |
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Basic information
Public title
Establishment of nationwide database related to gastroenterological endoscopy
Acronym
Japan endoscopy database (JED) project
Scientific Title
Establishment of nationwide database related to gastroenterological endoscopy
Scientific Title:Acronym
Japan endoscopy database (JED) project
Region
| Japan |
Condition
Condition
gastroenterological diseases (including both malignancy and non-malignancy)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
According to collecting all the nationwide data of gastroenterological endoscopy in Japan, we can clarify
1. characteristics of institutions and divisions where endoscopy is performed
2. evaluation of medical standards
3. allocation of appropriate numbers of endoscopy special doctors, nurses, engineers, etc
4. precise data collection of cancer registry
5. prognosis after endoscopy
6. social-economic data collection related to endoscopy
7. risk analyses of death or complications for endoscopy
etc
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
outcomes of endoscopy
Key secondary outcomes
complications of endoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with gastroeneterological endoscopy
Key exclusion criteria
none
Target sample size
9999999999
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Tanaka |
Organization
Japan Gastroenterological Endoscopy Society (JGES)
Division name
President
Zip code
101-0062
Address
3-2-1, Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
03-3525-4670
info@jges.or.jp
Public contact
Name of contact person
| 1st name | Kiyohito |
| Middle name | |
| Last name | Tanaka |
Organization
Japan Gastroenterological Endoscopy Society
Division name
JED project commitee
Zip code
101-0062
Address
3-2-1, Kanda Surugadai, Chiyoda-ku, Tokyo
TEL
03-3525-4670
Homepage URL
info@jges.or.jp
Sponsor or person
Institute
Japan Gastroenterological Endoscopy Society
(JGES)
Institute
Department
Personal name
Funding Source
Organization
Japan Gastroenterological Endoscopy Society
(JGES)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JGES ethical committee
Address
3-2-1, Kanda Surugadai, Chiyoda-ku, Tokyo
Tel
03-3525-4670
jges-rinri@jges.or.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter prospective cohort study
Management information
Registered date
| 2014 | Year | 12 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018690
| 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 |
