UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Acronym	Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Scientific Title	Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Scientific Title:Acronym	Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Region	Japan

Condition
Condition	Small colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prospectively evaluate the usefulness of endocytoscopy-based computer-aided diagnosis system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic abilities for detecting neoplastic change of small polyps;sensitivity, specificity, accuracy, positive predictive value, and negative predictive value
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Diagnosis by endoscopists
Interventions/Control_2	Diagnosis with use of the endocytoscopy-based computer-aided diagnosis system
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who undergo colonoscopy and detected of a small polyp (=<10mm) whose histology is unknown.
Key exclusion criteria	Inflamatory bowel disease Patients from whom clear endoscopic images are difficult to obtain
Target sample size	270

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Mori
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama
TEL	045-949-7693
Email	ibusiginjp@hotmail.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Mori
Organization	Showa University Northen Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama
TEL	045-949-7693
Homepage URL
Email	ibusiginjp@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	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University Northern Yokohama Hospital; Regonale Komiteer For Medisinsk Og Helsefaglig Forskningsetikk
Address	35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama; Gullhaugveien 1-3, 0484 Oslo
Tel	+81459497000
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	昭和大学横浜市北部病院消化器センター（神奈川県） Digestive Disease Center, Showa University Northern Yokohama Hospital (Kanagawa)

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 10 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	2014 Year 02 Month 01 Day
Date of IRB	2014 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 05 Month 09 Day
Last modified on	2022 Year 11 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016229