UMIN-CTR Clinical Trial

Basic information
Public title	Performance evaluation test for EndoBRAIN-00
Acronym	Test for EndoBRAIN-00
Scientific Title	The detection performance of EndoBRAIN-00 for colorelctal lesions.
Scientific Title:Acronym	The detection performance of EndoBRAIN-00 for colorelctal lesions.
Region	Japan

Condition
Condition	colorectal lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the detection performance of computer-aided detection program for colorectal polyp. Evaluate to exceed the sensitivity of 90%.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify whether the sensitivity of EB-00 for colorectal polyps exceeds 90%.
Key secondary outcomes	1. The specificity, PPV and NPV of EB-00. 2. The sensitivity, specificity, PPV and NPV for diminutive( <5mm) polyps. 3. The false positive rate of EB-00 4. The sensitivity, specificity, PPV and NPV for flat or depressed lesions. 5. The sensitivity, specificity, PPV and NPV for protruded lesions.

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who underwent colonoscopy at Showa University Northern Yokohama Hospital from October 2018 to January 2019. 2. Patients at the age of 18 years of age or older. 3. Patients who have no indication of denial about the use of data.
Key exclusion criteria	1. Inflammatory bowel disease 2. Hereditary polyposis(e.g. FAP) 3. Patients who are judged ineligible at the discretion of the researcher.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Shin-ei Middle name Last name Kudo
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1 Chigasaki-chuo, Tsuduki-ku, Yokohama
TEL	045-949-7265
Email	mmisawa@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Misawa
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1 Chigasaki-chuo, Tsuduki-ku, Yokohama
TEL	045-949-7265
Homepage URL
Email	mmisawa@med.showa-u.ac.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	AMED
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
Address	35-1, Chigasaki-chuo, Tsuduki, Yokohama
Tel	045-949-7000
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

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 17 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	400
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	No longer recruiting
Date of protocol fixation	2019 Year 04 Month 02 Day
Date of IRB	2019 Year 04 Month 12 Day
Anticipated trial start date	2019 Year 06 Month 17 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	The test was conducted by using recorded colonoscopy videos and the performance is measured.

Management information
Registered date	2019 Year 06 Month 13 Day
Last modified on	2020 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042231