UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of AI-assisted diagnosis software for colonoscopy images.
Acronym	Evaluation of AI-assisted diagnosis software
Scientific Title	Evaluation of computer-aided diagnosis system for colonic narrow-band imaging using artificial intelligence
Scientific Title:Acronym	Evaluation of AI for colonic NBI images
Region	Japan

Condition
Condition	Colonic epithelial lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop and evaluate a CAD system that presents whether the target lesion is an adenoma, non-adenoma, or sessile serrated adenoma when non-magnified and near-magnified images of NBI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivity of AI for colonic adenoma (=<10mm)
Key secondary outcomes	1. Specificity, accuracy, NPV and PPV of AI for colonic adenoma (=<10mm) 2. Sensitivity, specificity, accuracy, NPV and PPV of AI for colonic non-neoplasms (=<10mm) 3. Sensitivity, specificity, accuracy, NPV and PPV of AI for colonic sesile serrated adenoma/polyp (=<10mm) 4. Sensitivity, specificity, accuracy, NPV and PPV of AI by the morphology of the lesions.

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	1. 20 years old or older at the time of examination 2. Lesions with clear NBI images 3. Lesions that have been resected and pathological diagnosis has been obtained
Key exclusion criteria	1. Patients who refuse to participate. 2. Lesions in patients with inflammatory bowel disease in a broad sense 3. Lesions not captured by NBI imaging
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Misawa
Organization	Showa Universit Northen Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	Chigasaki chuo 35-1, Tsuduki, Yokohama
TEL	045-949-7000
Email	mmisawa@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Misawa
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	Chigasaki-chuo 35-1, Tsuduki, Yokohama
TEL	045-949-7000
Homepage URL
Email	mmisawa@med.showa-u.ac.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	JSPS KAKENHI
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University Northern Yokohama Hospital
Address	Chigasaki-chuo 35-1, Tsuduki, Yokohama
Tel	045-949-7000
Email	irb02syh@ofc.showa-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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 19 Day
Date of IRB	2020 Year 09 Month 16 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Colonoscopy images taken from January 2015 to the end of June 2021 will be included in the study. A part of the images (except for the last month of the study period) will be used for training of the CAD. The lesions taken during the last month of the study period that are not used for training will be used as test images for the CAD. The test images will be selected in accordance with the following criteria. Pathological diagnosis must be obtained for the test images, but pathological diagnosis is not required for the training images.

Management information
Registered date	2021 Year 06 Month 21 Day
Last modified on	2021 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050954