UMIN-CTR Clinical Trial

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
Email	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
Email	ykato@ai-ms.com

Sponsor
Institute	AI Medical Service Inc.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051058