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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038547
Receipt No. R000043837
Scientific Title computer-aided diagnostic system for endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis
Date of disclosure of the study information 2019/11/12
Last modified on 2020/06/09

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Basic information
Public title computer-aided diagnostic system for
endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis
Acronym EndoBRAIN-UC STUDY
Scientific Title computer-aided diagnostic system for
endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis
Scientific Title:Acronym EndoBRAIN-UC STUDY
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of computer-aided diagnosis software(EB-03) using colonoscopy still image database.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The accuracy of computer-aided diagnosis software(EB-03) for the presence of histological
inflammation (Geboes score 3.1 or more)
Key secondary outcomes The sensitivity of computer-aided diagnosis software(EB-03) for the presence of histological inflammation (Geboes score 3.1 or more)

The specificity of computer-aided diagnosis software(EB-03) for the presence of histological inflammation (Geboes score 3.1 or more)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Pts with ulcerative colitis who were underwent with endocytoscopy at Showa University Yokohama Northern Hospital between October 2016 and December 2017.

2)Pts with informed consent.
Key exclusion criteria 1)Pts whose examination video is not saved.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shin-ei
Middle name
Last name Kudo
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL 045-949-7000
Email kudos@med.showa-u.ac.jp

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 224-8503
Address Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama
TEL 045-949-7468
Homepage URL
Email yasuharumaeda610@hotmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization none
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 IRB in Showa University Northern Yokohama Hospital
Address Chigasaki-chuo 35-1, Tsuduki-ku, 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
2019 Year 11 Month 12 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 42
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
2019 Year 08 Month 04 Day
Date of IRB
2019 Year 08 Month 15 Day
Anticipated trial start date
2019 Year 08 Month 15 Day
Last follow-up date
2019 Year 11 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective study using still image data base.

Management information
Registered date
2019 Year 11 Month 11 Day
Last modified on
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043837

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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