UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059094 |
|---|---|
| Receipt number | R000065389 |
| Scientific Title | Multi-center randomized controlled study of endoscopic gastric cancer screening combined with AI |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/09/16 12:32:58 |
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Basic information
Public title
Investigation of endoscopic gastric cancer screening combined with AI as an alternative to double check system
Acronym
Study of endoscopic gastric cancer screening combined with AI
Scientific Title
Multi-center randomized controlled study of endoscopic gastric cancer screening combined with AI
Scientific Title:Acronym
RCT of endoscopic gastric cancer screening combined with AI
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether endoscopic gastric cancer screening using AI can replace double-checking.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
When comparing the gastric cancer detection rate in the AI group with the final gastric cancer detection rate in non-AI group, the AI group was non-inferior to the conventional group.
Key secondary outcomes
Comparison of the initial cancer detection rate, rate requiring further examination, positive predictive value, re-examination rate by double-check, and final cancer detection rate between the two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Combining AI with gastric cancer endoscopic screening
Interventions/Control_2
Non-combining AI with gastric cancer endoscopic screening
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
| 50 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have undergone endoscopic gastric cancer screening
Key exclusion criteria
Participants who did not complete the endoscopy examination
Participants who were determined to require further examination but did not undergo further examination
Participants who the principal investigator determined to be unsuitable as study subjects
Patients who are unable to express their own will due to dementia or impaired consciousness
Patients who are unable to give consent
Target sample size
10834
Research contact person
Name of lead principal investigator
| 1st name | Mototsugu |
| Middle name | |
| Last name | Kato |
Organization
Hokkaido Cancer Society
Division name
Medicine
Zip code
065-0026
Address
1-15, Higashi-14, Kita-26, Higashi-ku, Sapporo
TEL
0117485511
mkato1957@gmail.com
Public contact
Name of contact person
| 1st name | MOTOTSUGU |
| Middle name | |
| Last name | KATO |
Organization
Hokkaido Cancer Society
Division name
Medicine
Zip code
065-0026
Address
1-15, Higashi-14, Kita-26, Higashi-ku, Sapporo
TEL
09094352260
Homepage URL
mkato1957@gmail.com
Sponsor or person
Institute
Hokkaido Cancer Society
Institute
Department
Personal name
Kato Mototsugu
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyagi Cancer Society
Address
7-30, uESUGI-5, Aoba-ku, Sendai, MIyagi prefecture
Tel
022-263-1525
hpxmaseve2004@kind.ocn.ne.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 | 09 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065389
