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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027335
Receipt No. R000031321
Scientific Title Evaluation of the output of the novel computer-aided diagnosis system for histological healing of UC patients using endocytoscopy for predicting clinical outcome
Date of disclosure of the study information 2017/05/15
Last modified on 2017/05/14

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Basic information
Public title Evaluation of the output of the novel computer-aided diagnosis system for histological healing of UC patients using endocytoscopy for predicting clinical outcome
Acronym Evaluation of the output of the computer-aided diagnosis system for predicting clinical outcome.
Scientific Title Evaluation of the output of the novel computer-aided diagnosis system for histological healing of UC patients using endocytoscopy for predicting clinical outcome
Scientific Title:Acronym Evaluation of the output of the computer-aided diagnosis system for predicting clinical outcome.
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 a computer-aided diagnosis system for predicting Clinical outcome of UC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The comparison of the rate of exacerbation between CAD outputs.
Key secondary outcomes The comparison of the rate of steroid hospitalization and colectomy between CAD outputs.

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 Ulcerative colitis with clinical remission stage which were observed with CAD system
Key exclusion criteria Lesions whose images were unclear
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuharu Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL 0459497567
Email yasuharumaeda610@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasuharu Maeda
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL 0459497567
Homepage URL
Email yasuharumaeda610@hotmail.com

Sponsor
Institute Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 昭和大学横浜市北部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is to evaluate the clinical outcome of outputs based on comparisons with computer diagnosis for predicting histological healing.

Management information
Registered date
2017 Year 05 Month 14 Day
Last modified on
2017 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031321

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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