UMIN-CTR Clinical Trial

Basic information
Public title	Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Acronym	Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Scientific Title	Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Scientific Title:Acronym	Research on development of artificial intelligence (AI) for detection and classification of upper gastrointestinal cancers in endoscopic images
Region	Japan

Condition
Condition	upper gastrointestinal cancers
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Collection of endoscopic images of upper gastrointestinal cancers, development of an AI system for detection of upper gastrointestinal cancers, and assessment of an AI system performance by expert endoscopists
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	An accuracy of an AI system for detection of upper gastrointestinal cancers in endoscopic images
Key secondary outcomes	An accuracy of an AI system for classification of upper gastrointestinal cancers in endoscopic images

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)Patients undergoing endoscopy to inspect lesions suspicious for upper gastrointestinal cancers 2)Patients aged 20 years or older at the time of enrollment 3)Patients who have provided written informed consent to participate in this study
Key exclusion criteria	1)Patients after upper gastrointestinal surgery 2)Patients investigator judged unsuitable as the research subject
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Mitsuhiro Middle name Last name Fujishiro
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology & Hepatology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2172
Email	mtfujish@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Hirai
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology & Hepatology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2172
Homepage URL
Email	hiraik53@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The IRB of Nagoya University
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-2479
Email	iga-shinsa@adm.nagoya-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	2020 Year 04 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	Enrolling by invitation
Date of protocol fixation	2019 Year 10 Month 12 Day
Date of IRB	2019 Year 11 Month 19 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Upper gastrointestinal endoscopy will be performed for patients who meet the selection criteria between March 2020 and December 2021.Endoscopic images of lesions suspicious for upper gastrointestinal cancers and data about clinicopathologic characteristics will be collected.

Management information
Registered date	2020 Year 02 Month 25 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045155