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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046599
Receipt No. R000053122
Scientific Title A multicenter study for gastric lesion detection performance of Computer-Aided-Detection (CADe) program for endoscopy
Date of disclosure of the study information 2022/01/24
Last modified on 2022/01/11

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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


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