UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039645 |
|---|---|
| Receipt number | R000045218 |
| Scientific Title | Creation of an automatic diagnosis system for endoscopic images of esophageal disease using AI |
| Date of disclosure of the study information | 2020/03/30 |
| Last modified on | 2021/03/01 14:58:38 |
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Basic information
Public title
Creation of an automatic diagnosis system for endoscopic images of esophageal disease using
artificial intelligence
Acronym
Creation of an automatic diagnosis system for endoscopic images of esophageal disease using
artificial intelligence
Scientific Title
Creation of an automatic diagnosis system for endoscopic images of esophageal disease using AI
Scientific Title:Acronym
Creation of an automatic diagnosis system for endoscopic images of esophageal disease using AI
Region
| Japan |
Condition
Condition
Esophageal diseases (such as esophageal malignant tumors, leiomyomas, neuroendocrine tumors, granuloma, reflux esophagitis, and eosinophilic esophagitis) and normal esophagus
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To create an automatic diagnosis system for endoscopic images of esophageal disease using artificial intelligence (AI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis accuracy of various esophageal diseases using AI diagnostic system
Key secondary outcomes
Diagnosis sensitivity, specificity, positive predictive value, negative predictive value of various esophageal diseases using AI diagnostic system. Time required for diagnosis. Doctor's diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Esophageal diseases (such as esophageal malignant tumors, leiomyomas, neuroendocrine tumors, granuloma, reflux esophagitis, and eosinophilic esophagitis) and endoscopic images of normal esophagus (images / movies)
Key exclusion criteria
When the patient reject to use existing information through an information disclosure document published on the homepage of the facility.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
Osaka International Cancer Institute.
Division name
Gastrointestinal Oncology
Zip code
541-8567
Address
1-69 Otemae 3-chome, Chuo-ku, Osaka541-8567, Japan
TEL
06-6945-1181
ryu1486@gmail.com
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Waki |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal Oncology
Zip code
541-8567
Address
1-69 Otemae 3-chome, Chuo-ku, Osaka541-8567, Japan
TEL
06-6945-1181
Homepage URL
waki-ko@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Gastrointestinal Oncology
Institute
Department
Personal name
Funding Source
Organization
Tada Tomohiro AI Endoscopic Diagnostic System Verification Fund
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tada Tomohiro Institute of Gastroenterology and Proctology
Nigata University Graduate School of medical and Dental Science
Department of Gastroenterology, Fukuoka University hospital
AI Medical Service Inc.
Department of Gastroenterology and Hepatology, Kumamoto University Hospital
Department of Gastroenterology and Hepatology, Kumamoto chuo hospital
Department of Gastroenterology and Hepatology,Keio University Hospital
Department of Endoscopic Medicine, Mie University Hospital
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute, Ethics Committee
Address
1-69 Otemae 3-chome, Chuo-ku, Osaka541-8567, Japan
Tel
06-6945-1181
rinri01@opho.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
| 2020 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/den.13934
Number of participants that the trial has enrolled
21
Results
We prepared 100 video datasets, including 50 superficial ESCCs, 22 noncancerous lesions, and 28 normal esophagi. The AI system had sensitivity of 85.7% (54 of 63 ESCCs) and specificity of 40%. Initial evaluation by endoscopists conducted with plain video (without AI support) had average sensitivity of 75.0% (47.3 of 63 ESCC) and specificity of 91.4%.
Results date posted
| 2021 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 27 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Multicenter observational study
From the electronic medical record system and the endoscopic image server, the diagnosis information, the treatment information, and the endoscopic images of the patient having the esophageal disease are extracted after the anonymization processing. Similarly, it is extracted after the anonymization processing of the diagnosis information of the patient having the normal esophagus and the endoscopic images. Upload the extracted information and images to the server of AI medical service, which is responsible for developing the AI diagnostic system. AI medical service educates AI about 90% of the images classified by diagnosis name, and uses the remaining 10% of the images as verification images to evaluate the diagnostic accuracy of the AI diagnosis system for esophageal disease.
We have the doctors who actually work in endoscopic practice diagnose the images and videos collected in our hospital after anonymization processing and compare them with the diagnostic accuracy of AI.
Management information
Registered date
| 2020 | Year | 02 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045218
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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