UMIN-CTR Clinical Trial

Basic information
Public title	Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients using endocytoscopy
Acronym	Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients
Scientific Title	Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients using endocytoscopy
Scientific Title:Acronym	Construction of the novel computer-aided diagnosis system for predicting histologic inflammatory severity of Ulcerative colitis patients
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 develop and evaluate a computer-aided diagnosis system for histological inflammatory severity of UC.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for predicting persist of histologic inflammation in segment-based analysis.
Key secondary outcomes	Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for predicting persist of histologic inflammation in segments with mucosal healing. Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for predicting persist of histologic inflammation in patient-based analysis.

Base
Study type	Others,meta-analysis etc

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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	UC patients who were taken biopsy after observation with endocytoscopy
Key exclusion criteria	None
Target sample size	200

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	Grants in Aid for Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Government offices of other countries
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 05 Month 06 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 04 Month 30 Day
Date of IRB	2018 Year 04 Month 30 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2021 Year 11 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	endoscopic images are allocated to an automated diagnosis sysetm and endoscopists for assessment of accuracy of pathological prediction. Diganostic accuracies, and confidence levels are evaluated.

Management information
Registered date	2018 Year 05 Month 06 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037031