UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054770 |
|---|---|
| Receipt number | R000062551 |
| Scientific Title | Usefulness of AI in Gastric Biopsy Lesions |
| Date of disclosure of the study information | 2024/06/26 |
| Last modified on | 2024/11/29 16:26:01 |
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Basic information
Public title
Usefulness of AI in Gastric Biopsy Lesions
Acronym
Usefulness of AI in Gastric Biopsy Lesions
Scientific Title
Usefulness of AI in Gastric Biopsy Lesions
Scientific Title:Acronym
Usefulness of AI in Gastric Biopsy Lesions
Region
| Japan |
Condition
Condition
gastric epithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Gastro AI model-G by AI medical is expected to improve diagnostic accuracy by analyzing whether lesions suspected to be epithelial tumors in the stomach discovered by endoscopists are candidates for additional testing such as biopsy, and by collaborating with endoscopists and AI. However, there have been no reports to date that have examined the diagnostic accuracy of tumors by endoscopists and AI in clinical practice. This study aims to clarify the diagnostic accuracy of tumors by endoscopists and AI, and to examine the clinical usefulness of an AI-based endoscopic image diagnostic system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of endoscopists and AI in cases of suspected gastric epithelial tumors undergoing biopsy
Key secondary outcomes
Diagnostic accuracy of gastric epithelial tumors by specialists and non-specialists
Accuracy rate, sensitivity and specificity of AI in cases where endoscopists diagnosed a tumor and performed a biopsy, and cases where they diagnosed a non-tumor but performed a biopsy to confirm
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients performed biopsy for gastric lesion by using the gastro AI-model G.
Key exclusion criteria
Lesions that have already been diagnosed as tumors through biopsy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Shigehisa |
Organization
Japanese Red Cross Kochi Hospital
Division name
Gastroenterology
Zip code
780-8562
Address
1-4-63-11,Hadaminami-machi, Kochi-shi, Kochi prefecture
TEL
088-822-1201
yurikonoguchi630@gmail.com
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Shigehisa |
Organization
Japanese Red Cross Kochi Hospital
Division name
Gastroenterology
Zip code
780-8562
Address
1-4-63-11,Hadaminami-machi, Kochi-shi, Kochi prefecture
TEL
088-822-1201
Homepage URL
yurikonoguchi630@gmail.com
Sponsor or person
Institute
Japanese Red Cross Kochi Hospital
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
Japanese Red Cross Kochi Hospital
Address
1-4-63-11,Hadaminami-machi, Kochi-shi, Kochi prefecture
Tel
088-822-1201
yurikonoguchi630@gmail.com
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
| 2024 | Year | 06 | Month | 26 | 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
| 2024 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | 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
When considering a biopsy for a lesion suspected to be a gastric epithelial tumor during upper gastrointestinal endoscopy, the endoscopist will perform the biopsy as usual, and the analysis results regarding the need for a biopsy by gastroAI model-G will be displayed simultaneously on a separate monitor without being seen by the endoscopist, and the analysis results will be recorded by a third party. The accuracy rate of endoscopists and AI will be retrospectively examined.
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062551
