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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044705
Receipt No. 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 2021/06/29

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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
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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 316
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 No longer recruiting
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
2021 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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