UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061466 |
|---|---|
| Receipt number | R000070333 |
| Scientific Title | Observational study of newly detected gastric cancer after intensive esophagogastroduodenoscopy (I-EGD) in high-risk populations |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/06 21:27:06 |
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Basic information
Public title
Observational study of newly detected gastric cancer after intensive esophagogastroduodenoscopy (I-EGD) in high-risk populations
Acronym
Observational study of newly detected gastric cancer after intensive esophagogastroduodenoscopy (I-EGD) in high-risk populations
Scientific Title
Observational study of newly detected gastric cancer after intensive esophagogastroduodenoscopy (I-EGD) in high-risk populations
Scientific Title:Acronym
Observational study of newly detected gastric cancer after intensive esophagogastroduodenoscopy (I-EGD) in high-risk populations
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term cumulative incidence and clinicopathological characteristics of newly detected gastric cancer after intensive esophagogastroduodenoscopy (I-EGD) in patients who completed the WLI/2G-NBI protocol in the EGC Detection Trial (UMIN000014503)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative incidence of newly detected gastric cancer after I-EGD. The date of I-EGD will be defined as the time origin, and the first diagnosis of newly detected gastric cancer after I-EGD will be defined as the event.
Key secondary outcomes
Key secondary outcomes include subgroup-specific cumulative incidence of newly detected gastric cancer after I-EGD, clinical and clinicopathological characteristics of patients and lesions with newly detected gastric cancer, treatment modality and curability of endoscopic resection, and retrospective detectability of newly detected gastric cancer on the preceding surveillance EGD images.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were enrolled in the EGC Detection Trial.
Key exclusion criteria
1. Patients who did not complete protocol-defined intensive esophagogastroduodenoscopy (I-EGD) using white light imaging (WLI) and second-generation narrow band imaging (2G-NBI) in the EGC Detection Trial.
2. Patients for whom information on post-I-EGD esophagogastroduodenoscopy is unavailable.
3. Patients who opted out of the use of their clinical information for this study.
Target sample size
4400
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Medical Oncology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan
TEL
075-751-4592(81-75-751-4592)
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Yoshida |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
920-8530
Address
2-1 Kuratukihigashi Kanazawa, Ishikawa, 920-8530, Japan
TEL
076-237-8211(81-76-237-8211)
Homepage URL
naohilowg@gmail.com
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Kawaharacho, Shogoin, Sakyo, Kyoto, 606-8507, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2026 | Year | 05 | Month | 11 | 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
4529
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
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective cohort study without any new intervention or allocation. Patients enrolled in the EGC Detection Trial who completed I-EGD using WLI and 2G-NBI will be evaluated using existing trial data and medical record data. The study will assess the cumulative incidence and clinicopathological characteristics of newly detected gastric cancer after I-EGD. No new intervention, examination, or treatment will be assigned. Factors to be evaluated include age, sex, baseline indication, gastric cancer detection at index I-EGD, number of registrations, degree of gastric mucosal atrophy, and Helicobacter pylori infection status. This study does not use random sampling; eligible patients will be selected based on completion of I-EGD and availability of post-I-EGD medical record information.
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070333
