UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of ulcerative colitis with deep neural networks based on endoscopic images
Title of the study (Brief title)	DNN-UC
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to evaluate the varidity of deep neural networks for ulcerative colitis (DNN-UC)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	accuracy of DNN-UC to evaluate endoscopic and histological healing
Key secondary outcomes	i) ability of DNN-UC to score UCEIS ii) accuracy of DNN-UC for endoscopic and histological healing in each segment iii) accuracy of DNN-UC in each confidence case iv) accuracy of DNN-UC stratified with the degree of colon cleaning.

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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	the patients who underwent colonoscopy for evaluation of UC
Key exclusion criteria	i) patients with prior colon surgery, IBD unclassified, Crohns disease, colorectal neoplasia, or concomitant infectious colitis ii) patients for whom colonoscopy were contraindicated iii) patients for whom biopsy were contraindicated because of blood disease or antithrombotic or anticoagulation therapy.
Target sample size	500

Research contact person
Name of lead principal investigator	Kazuo Ohtsuka
Organization	Tokyo Medical and Dental University
Division name	Department of Endoscopy
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5877
Email	kohtsuka.gast@tmd.ac.jp

Public contact
Name of contact person	Kento Takenaka
Organization	Tokyo Medical and Dental University
Division name	Department of Endoscopy
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5877
Homepage URL
Email	ktakenaka.gast@tmd.ac.jp

Sponsor
Institute	Department of Endoscopy, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	the Cooperation Program between Tokyo Medical and Dental University and Sony Imaging Products & Solutions Inc.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2018 Year 03 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 01 Month 15 Day
Date analysis concluded	2018 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Perform colonoscopy, capture endoscopic images, and perform biopsy from each 5 segments

Management information
Registered date	2018 Year 02 Month 22 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035833