UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of assistive system of histological remission diagnosis of ulcerative colitis by magnified NBI image using artificial intelligence
Acronym	Evaluation of diagnostic assistance system using enlarged NBI images
Scientific Title	Evaluation of assistive system of histological remission diagnosis of ulcerative colitis by magnified NBI image using artificial intelligence
Scientific Title:Acronym	Evaluation of diagnostic assistance system using enlarged NBI images
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Develop and evaluate a diagnostic assistance system using artificial intelligence that can diagnose histological remission using magnified NBI images.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of the percentage of histological inflammation by AI diagnostic output
Key secondary outcomes	Clinical relapse rate after 1 year by diagnosis of AI diagnostic output

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 with a definite diagnosis of ulcerative colitis in advance Patients undergoing lower gastrointestinal endoscopy due to clinical need Patients who are 20 years of age or older at the time of consent acquisition Patients with no history of radiation therapy for the abdomen or pelvis
Key exclusion criteria	Patients who have been asked to refuse to participate in this study Patients who did not undergo histological diagnosis
Target sample size	100

Research contact person
Name of lead principal investigator	1st name YASUHARU Middle name Last name MAEDA
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
TEL	+81459497000
Email	yasuharumaeda610@hotmail.com

Public contact
Name of contact person	1st name YASUHARU Middle name Last name MAEDA
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
TEL	+81459497000
Homepage URL
Email	yasuharumaeda610@hotmail.com

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Showa University Northern Yokohama Hospital Digestive Disease Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University Northern Yokohama Hospital Digestive Disease Center
Address	35-1 Chigasakichuo Tuduki-ku yokohama kanagawa
Tel	+81459497000
Email	yasuharumaeda610@hotmail.com

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 07 Month 27 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 07 Month 26 Day
Date of IRB
Anticipated trial start date	2021 Year 07 Month 27 Day
Last follow-up date	2024 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Develop and evaluate a diagnostic assistance system using artificial intelligence that can diagnose histological remission using magnified NBI images

Management information
Registered date	2021 Year 07 Month 26 Day
Last modified on	2022 Year 01 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051347