UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059946 |
|---|---|
| Receipt number | R000068565 |
| Scientific Title | Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination |
| Date of disclosure of the study information | 2025/12/02 |
| Last modified on | 2025/12/02 14:52:37 |
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Basic information
Public title
Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination
Acronym
Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination
Scientific Title
Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination
Scientific Title:Acronym
Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination Clinical Characteristics of Gastric Cancer Occurring After Bacteria Elimination
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the clinical characteristics of gastric cancer occurring after Helicobacter pylori eradication and to evaluate its association with background diseases and patient profiles at the time of eradication. Specifically, we will conduct a detailed analysis of endoscopic findings before and after eradication, the degree of atrophic gastritis, the incidence rate of gastric cancer after eradication, and the characteristics of the resulting gastric cancers, including location, morphology, size, depth of invasion, and histological type. This aims to understand the characteristics of gastric cancers developing after eradication and to gain insights that will contribute to improving future treatment and preventive strategies.
Basic objectives2
Others
Basic objectives -Others
Characterizing gastric cancer occurring after eradication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Background Diseases and Patient Profiles at the Time of Eradication with Characteristics of Gastric Cancer Occurring After Helicobacter pylori Eradication
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients aged 18 years or older at the time of Helicobacter pylori eradication therapy who underwent treatment at Keio University Hospital between January 2012 and August 2024 and were subsequently newly diagnosed with gastric cancer by October 2024.
Key exclusion criteria
1 Individuals who refused to allow their clinical data to be used. 2 Patients who had concomitant gastric cancer planned for treatment during Helicobacter pylori eradication therapy. 3 Patients who received Helicobacter pylori eradication therapy at another hospital.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
mori-d@keio.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
mori-d@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
0333531211
med-rinri-ft_pt@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
42
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 24 | 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
Retrospective study
Management information
Registered date
| 2025 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068565
