UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024943 |
|---|---|
| Receipt number | R000028698 |
| Scientific Title | The characteristics of gastric cancer detected after successful H.pylori eradication |
| Date of disclosure of the study information | 2016/11/22 |
| Last modified on | 2016/11/22 11:21:20 |
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Basic information
Public title
The characteristics of gastric cancer detected after successful H.pylori eradication
Acronym
The characteristics of gastric cancer detected after successful H.pylori eradication
Scientific Title
The characteristics of gastric cancer detected after successful H.pylori eradication
Scientific Title:Acronym
The characteristics of gastric cancer detected after successful H.pylori eradication
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The clinicopathological characteristics of gastric cancer detected after successful H.pylori eradication were investigated.
Basic objectives2
Others
Basic objectives -Others
The primary outcomes between patients with active H.pylori infection and H.pylori eradicated were compared.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, sex, location of tumor, diameter of tumor, histological type of tumor, macroscopic type of tumor, the degree of background mucosal atrophy, the period from successful eradication to detection of gastric cancer (for eradicated patients only), and the reason of eradication (for eradicated patients only) in each patient
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients who underwent endoscopic resection of gastric cancer at Kyoto Prefectural University of Medicine, between January 2009 and June 2014
Key exclusion criteria
The cases that were not examined for H. pylori infection
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Majima |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
075-251-5519
Homepage URL
a-majima@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 11 | Month | 22 | 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
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2016 | Year | 11 | Month | 22 | Day |
Last modified on
| 2016 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028698
