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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034235
Receipt No. R000039023
Scientific Title Establishment of computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy
Date of disclosure of the study information 2018/09/21
Last modified on 2019/09/26

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Basic information
Public title Establishment of computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy
Acronym UC-CAD study
Scientific Title Establishment of computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy
Scientific Title:Acronym UC-CAD study
Region
Japan

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

Objectives
Narrative objectives1 To establish a computer-assisted diagnosis support system as an artificial intelligence function for management of ulcerative colitis using endocytoscopy, and evaluate the efficacy of AI system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes a computer-assisted diagnosis support system as an artificial intelligence function to predict endoscopic pathological healing
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 When observe using endocytoscope(NBI), take a biopsy
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 eligible patients
>who were diagnosed with Ulcerative Colitis,
>who need lower GI observation in their clinical coarse,
>who are 20 years of age or more
Key exclusion criteria Patients are excluded if
>they have a history of radiation therapy to their abdomen,
>it is impossible to take a biopsy because of the blood disorders or under anticoagulant therapy,
>they reject to join this clinical study.
Target sample size 850

Research contact person
Name of lead principal investigator
1st name Haruhiko
Middle name
Last name Ogata
Organization Keio University Schoool of Medicine
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code 1608582
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email hogata@z8.keio.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Mutaguchi
Organization Keio University Schoool of Medicine
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code 1608582
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email ma.mutaguchi@gmail.com

Sponsor
Institute Keio University Schoool of Medicine
Institute
Department

Funding Source
Organization Keio University Schoool of Medicine, Center for Diagnostic and Therapeutic Endoscopy
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Syowa University Northern Yokohama Hospital
National University Corporation Tokyo Medical and Dental University
Nagoya university
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Review Committee
Address 35 Shinanomachi Shinjuku-ku, Tokyo
Tel 0333531211
Email ma.mutaguchi@gmail.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 昭和大学横浜市北部病院
東京医科歯科大学医学部附属病院
名古屋大学

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 21 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 21 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039023

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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