UMIN-CTR Clinical Trial

Basic information
Public title	Performance evaluation of computer-Aided gastric lesion detection program with artificial intelligence (AI) for endoscopy
Acronym	Performance evaluation of computer-Aided gastric lesion detection program for endoscopy
Scientific Title	A multicenter study for gastric lesion detection performance of Computer-Aided-Detection (CADe) program for endoscopy
Scientific Title:Acronym	Performance evaluation of endoscopy CADe program
Region	Japan

Condition
Condition	Localized gastric lesions
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the gastric lesion detection performance of the endoscopy CADe program
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity of the CADe program for detecting the gastric lesions
Key secondary outcomes	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the total frames of gastric lesions to be analyzed

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	Patients who undergo upper gastrointestinal endoscopy at the institutions during the study period.
Key exclusion criteria	Patients who: - underwent total gastrectomy; - are under the age of 20; - do not agree to participate in this study; - cannot follow instructions of this study and endoscopy and; - are judged to be inappropriate as a subject of this study by the investigator, for other reasons.
Target sample size	267

Research contact person
Name of lead principal investigator	1st name Kenshi Middle name Last name Yao
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Endoscopy
Zip code	818-8502
Address	1-1-1 Zokumyoin, Chikushino-shi, Fukuoka
TEL	092-921-101
Email	yao@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Kenshi Middle name Last name Yao
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Endoscopy
Zip code	818-8502
Address	1-1-1 Zokumyoin, Chikushino-shi, Fukuoka
TEL	092-921-1011
Homepage URL
Email	yao@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	OLYMPUS Medical Systems Corp
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	Fukuoka University-Medical Ethics Review Board
Address	7-45-1 Nanakuma, Jonan-kuFukuoka 814-0180, JAPAN
Tel	092-801-1011
Email	fumed-ethics@fukuoka-u.ac.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	静岡がんセンター（静岡県）、千葉大学医学部附属病院（千葉県）、 神戸市立医療センター中央市民病院（兵庫県）、 オリンパスメディカルシステムズ株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 24 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
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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 14 Day
Date of IRB	2021 Year 10 Month 06 Day
Anticipated trial start date	2022 Year 01 Month 26 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A total of three institutes participating in this joint study including Fukuoka University Chikushi Hospital perform upper gastrointestinal endoscopy. The performance of the endoscopy CADe program is evaluated with videos, which are recorded during the endoscopy after obtaining informed consent from the patients.

Management information
Registered date	2022 Year 01 Month 11 Day
Last modified on	2022 Year 01 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053122

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.