UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004594 |
|---|---|
| Receipt number | R000005369 |
| Scientific Title | Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer |
| Date of disclosure of the study information | 2010/11/21 |
| Last modified on | 2010/11/20 17:34:18 |
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Basic information
Public title
Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Acronym
Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Scientific Title
Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Scientific Title:Acronym
Multicenter trial for the relationship between atrophic change on endoscopic finding and gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The relationship among the atrophic change on endoscopic finding, interval of the precedures and gastric cancer
Basic objectives2
Others
Basic objectives -Others
comparison among each group
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of gastric cancer in each group
Key secondary outcomes
Pathohistrogical characteristics of the gastric cancer and the atrophic change on endoscopic finding
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
Pathient whose informed concent was obtained
Key exclusion criteria
Patient whose infromed concent was not obtained
Target sample size
32000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Matsuda |
Organization
The Jikei University Aoto Hospital
Division name
Department of endoscopy
Zip code
Address
6-41-2 Aoto, Katsushika, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University Aoto Hospital
Division name
Department of protection of personal information
Zip code
Address
TEL
03-3603-2111
Homepage URL
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oda GI clinic, Kitasato University Hosptial East, Kyoto second red cross hospital
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
東京慈恵会医科大学附属青戸病院（東京都）、尾田胃腸科内科（熊本県）、北里大学東病院（神奈川県）、京都第二日赤病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 21 | 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
| 2008 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The atrophic change in the gastric mucosa on endoscopic finding has a potential to predict the high risk group for the gastric cancer. The careful endoscopic follow-up would be recommended in cases with severe atrophic change on endoscopy. However, the natural history seemed different between the intestinal or mixed type, and the gastric type.
Management information
Registered date
| 2010 | Year | 11 | Month | 20 | Day |
Last modified on
| 2010 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005369
