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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031430
Receipt No. R000035833
Scientific Title Evaluation of ulcerative colitis with deep neural networks based on endoscopic images
Date of disclosure of the study information 2018/03/15
Last modified on 2019/02/25

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Basic information
Public title Evaluation of ulcerative colitis with deep neural networks based on endoscopic images
Acronym DNN-UC
Scientific Title Evaluation of ulcerative colitis with deep neural networks based on endoscopic images
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo Ohtsuka
Organization Tokyo Medical and Dental University
Division name Department of Endoscopy
Zip code
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
1st name
Middle name
Last name Kento Takenaka
Organization Tokyo Medical and Dental University
Division name Department of Endoscopy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000035833

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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