UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059254 |
|---|---|
| Receipt number | R000067775 |
| Scientific Title | An exploratory observational study to examine the additional benefit of the CADe program aimed at supporting early gastric cancer detection by endoscopy |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/10/01 09:56:25 |
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Basic information
Public title
An exploratory observational study to examine the additional benefit of the CADe program aimed at supporting early gastric cancer detection by endoscopy
Acronym
An exploratory observational study to examine the additional benefit of the CADe program aimed at supporting early gastric cancer detection by endoscopy
Scientific Title
An exploratory observational study to examine the additional benefit of the CADe program aimed at supporting early gastric cancer detection by endoscopy
Scientific Title:Acronym
An exploratory observational study to examine the additional benefit of the CADe program aimed at supporting early gastric cancer detection by endoscopy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To exploratory study the additional benefit of CADe, which was developed to support the endoscopic detection of early gastric cancer, on the diagnostic ability of endoscopists using existing data (endoscopic video).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of gastric cancer patients detected only by second reading (when used in conjunction with the CADe program)
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for acquired endoscopic video information
Patients aged 20 years or older
Patients who have personally agreed to participate in the previous study
Patients who have not undergone total gastrectomy
Patients who have been found to have early gastric cancer through prior testing
Patients who have not been enrolled in other studies in the previous study
Patients who have been deemed by the previous study to be able to comply with instructions regarding the previous study and testing
Patients who have been deemed appropriate for participation in the previous study by the principal investigator (co-investigator)
Inclusion criteria for readers
- Physicians who perform upper gastrointestinal endoscopy as part of their daily work.
- Of the above criteria, an expert endoscopist is defined as someone who holds specialist certification from the Japan Gastroenterological Endoscopy Society and has more than 10 years of experience in gastrointestinal endoscopy, while a non-expert endoscopist is defined as someone who does not hold specialist certification from the Japan Gastroenterological Endoscopy Society and has less than 10 years of experience in gastrointestinal endoscopy.
Key exclusion criteria
Exclusion criteria for acquired endoscopic video information
Cases in which systematic and comprehensive lesion exploration of the entire gastric mucosa was not performed
Exclusion criteria for readers
A doctor who the principal investigator considers unsuitable to conduct this study
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Clinical Medicine Research Center
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka Prefecture
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Miyaoka |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of endoscopy
Zip code
818-8502
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka Prefecture
TEL
08052523770
Homepage URL
miyaoka1@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
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
Fukuoka University - Ethics Review Board
Address
7-45-1 Nanakuma, Jonan Ward, Fukuoka City, Fukuoka Prefecture
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2025 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067775
