UMIN-CTR Clinical Trial

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

gastric lesion

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

AI Medical Service Inc.

Institute

Department

Personal name

Organization

AI Medical Service Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

06

Month

29

Day

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1111/den.14455

Publication of results

Published

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

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 related information

Endoscopists select endoscopic images, and pathologists give re-diagnoses to pathological specimens that the endoscopists selected.

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