UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044705 |
|---|---|
| Receipt number | R000051058 |
| Scientific Title | Validation study of computer-aided diagnostic system for endoscopic image of gastric lesion |
| Date of disclosure of the study information | 2021/06/29 |
| Last modified on | 2022/11/29 18:50:13 |
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Basic information
Public title
Validation study of computer-aided diagnostic system for endoscopic image of gastric lesion
Acronym
Validation study of Tango
Scientific Title
Validation study of computer-aided diagnostic system for endoscopic image of gastric lesion
Scientific Title:Acronym
Validation study of Tango
Region
| Japan |
Condition
Condition
gastric lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic ability of computer-aided diagnostic system, Tango to endoscopists (Experts and Non-experts).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Sensitivity; demonstrate Tango is not inferior to experts
Key secondary outcomes
(1) Accuracy; demonstrate Tango is not inferior to experts
(2) Sensitivity/Accuracy; demonstrate Tango is superior to non-experts
(3) Specificity/PPV; Tango, experts, and non-experts
(4) Response time; Tango, experts, and non-experts
(5) Differences in performance; Olympus system and Fujifilm system
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 and images that meet all of inclusion criteria below.
(1) Endoscopic images taken with Olympus and Fujifilm endoscopic systems at The Cancer Institute Hospital Of JFCR and Jichi Medical University Hospital, respectively.
(2) Endoscopic images taken from January 1st, 2019 to August 31st, 2020.
(3) Endoscopic images saved in the on-site endoscopic management systems.
(4) Pathological samples, which were taken by biopsy (non-neoplasm) or ESD/EMR (adenoma or adenocarcinoma) or those images are stored.
(5) One lesion for one patient when multi-lesions were diagnosed in the patient. The higher priority for treatment will be selected.
(6) White light endoscopy
(7) Non-chromoendoscopy for the lesion
(8) Equal to or greater than 256 x 256px
(9) Inadequate images for diagnosis judged by the certified endoscopists (out of use condition, artifacts like devices or foreign bodies, inadequate wash, halation/blurring, out of focus, inable to anonymize such as rare case were excluded )
(10) Regardless of sizes/location of lesion or age/gender of patients
Key exclusion criteria
(1) Advanced gastric cancer
(2) Consent has been revoked by opt-out
(3) Lesions that is too large to fit in rectangular area inscribed in endoscopic images.
(4) Smaller than 256 x 256px after anonymization.
(5) Pathological diagnosis is "undecidable", which is Group X or Group 2 by the Group Classification or disagreement of pathologists
Target sample size
316
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kato |
Organization
AI Medical Service Inc.
Division name
R&D
Zip code
170-0013
Address
Hareza Tower 11F, 1-18-1, Higashi-ikebukuro, Toshima-ku, Tokyo
TEL
03-6903-1028
ykato@ai-ms.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kato |
Organization
AI Medical Service Inc.
Division name
R&D
Zip code
170-0013
Address
Hareza Tower 11F, 1-18-1, Higashi-ikebukuro, Toshima-ku, Tokyo
TEL
03-6903-1028
Homepage URL
ykato@ai-ms.com
Sponsor or person
Institute
AI Medical Service Inc.
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
MINS, Approved Specified Nonprofit Corporation
Address
ST Shibuya building 2F, 1-15-14, Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.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
| 2021 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/den.14455
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/den.14455
Number of participants that the trial has enrolled
315
Results
Tango (84.7%) achieved superiority over the specialists (65.8%) and non-specialists (51.0%) based on sensitivity.
Results date posted
| 2022 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 14 | Day |
Baseline Characteristics
Patients with a gastric lesion, which endoscopic image was taken
Participant flow
Endoscopic images of gastric lesions previously diagnosed at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research and Jichi Medical University Hospital between January 2019 and August 2020 was extracted.
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endoscopists select endoscopic images, and pathologists give re-diagnoses to pathological specimens that the endoscopists selected.
Management information
Registered date
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | 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=R000051058
