UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059857 |
|---|---|
| Receipt number | R000067974 |
| Scientific Title | Development and Performance Validation of Artificial Intelligence-Assisted Image Analysis Software for the Diagnosis of Gastric Intestinal Metaplasia |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/22 16:45:47 |
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Basic information
Public title
Development and Performance Validation of Artificial Intelligence-Assisted Image Analysis Software for the Diagnosis of Gastric Intestinal Metaplasia
Acronym
Development and Validation of an AI System for Diagnosing Gastric Intestinal Metaplasia
Scientific Title
Development and Performance Validation of Artificial Intelligence-Assisted Image Analysis Software for the Diagnosis of Gastric Intestinal Metaplasia
Scientific Title:Acronym
Development and Validation of an AI System for Diagnosing Gastric Intestinal Metaplasia
Region
| Japan |
Condition
Condition
gastric intestinal metaplasia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop and validate an AI-assisted image analysis software for the diagnosis of gastric intestinal metaplasia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic sensitivity of the developed AI for gastric intestinal metaplasia
Key secondary outcomes
1. Diagnostic specificity of gastric intestinal metaplasia (IM) by the developed AI
2. Diagnostic sensitivity and specificity of IM based on physicians' endoscopic diagnosis
3. Concordance rate of OLGA/OLGIM grading between the developed AI and histopathology
4. Concordance rate of OLGA/OLGIM grading between physicians' endoscopic diagnosis and histopathology
5. Diagnostic sensitivity and specificity of IM using the virtual chromoendoscopy program
6. Diagnostic accuracy of IM stratified by physicians' level of experience
7. Diagnostic accuracy of IM stratified by patient characteristics
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Two biopsies of the gastric mucosa for histopathological confirmation of intestinal metaplasia.
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
1. Patients aged 18 years or older.
2. Patients who meet either of the following conditions (i) or (ii):
(i) Patients diagnosed with atrophic gastritis (AG) or intestinal metaplasia (IM) in previous endoscopic examinations.
(ii) Patients currently infected with Helicobacter pylori or who have undergone eradication therapy in the past.
3. Patients from whom written informed consent for participation in this study has been obtained.
Key exclusion criteria
1. Patients who are unable to discontinue antithrombotic medication.
2. Pregnant women or women who may be pregnant.
3. Others.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
International University of Health and Welfare, Ichikawa Hospital
Division name
Gastroenterology
Zip code
272-0827
Address
6-1-14 Kokubunadai, Ichikawa-shi, Chiba 272-0827, Japan
TEL
047-375-1111
s.sho.salubriter.mail@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
International University of Health and Welfare, Ichikawa Hospital
Division name
Gastroenterology
Zip code
272-0827
Address
6-1-14 Kokubunadai, Ichikawa-shi, Chiba, Japan
TEL
047-375-1111
Homepage URL
s.sho.salubriter.mail@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
AI Medical Service Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Chiba District Ethics Review Committee
Address
4-3 Kozunomori, Narita-shi, Chiba, Japan
Tel
0476-20-7701
rinri_md@ihwg.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
国際医療福祉大学市川病院（千葉県）、国際医療福祉大学成田病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | 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 | 13 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067974
