UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Construction of the novel computer-aided diagnosis system for predicting histological healing of UC patients using endocytoscopy
Title of the study (Brief title)	Construction of the novel computer-aided diagnosis system for histological healing using endocytoscopy
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 healing 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 histological healing in patient-based analysis.
Key secondary outcomes	Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) for histological healing in segment-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	100

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

Public contact
Name of contact person	Yasuharu Maeda
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
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)

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 02 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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 02 Month 17 Day
Last modified on	2018 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035787