UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter validation study on computer-aided diagnostic system for endocytoscopic image in diagnosis of colrectal lesions
Title of the study (Brief title)	EndoBRAIN STUDY
Region	Japan

Condition
Condition	Colorectal lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare the diagnostic capability with the endoscopist (non specialist) about the pathological diagnosis prediction ability of the endoscopic diagnosis support software EndoBRAIN.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Confirm the accuracy of diagnosis in the case of using a ultra-high magnified staining image in distinguishing neoplasm from non-neoplasm in colorectal lesion of 10 mm or less.(Verification that EndoBRAIN is superior to non-specialist in diagnostic accuracy) 2.Confirm the specificity of diagnosis in the case of using a ultra-high magnified staining image in distinguishing neoplasm from non-neoplasm in colorectal lesion of 10 mm or less.(Verification that EndoBRAIN is superior to non-specialist in diagnostic accuracy) 3.Confirm the accuracy of diagnosis in the case of using a ultra-high magnified narrow-banding image(NBI) in distinguishing neoplasm from non-neoplasm in colorectal lesion of 10 mm or less.(Verification that EndoBRAIN is superior to non-specialist in diagnostic accuracy) 4.Confirm the specificity of diagnosis in the case of using a ultra-high magnified narrow-banding image (NBI) in distinguishing neoplasm from non-neoplasm in colorectal lesion of 10 mm or less.(Verification that EndoBRAIN is superior to non-specialist in diagnostic accuracy)
Key secondary outcomes	1.Accuracy of distinguishing neoplasm from non-neoplasm of 10 mm or less colorectal lesion. 2.Whether either of diagnosis accuracy, sensitivity, specificity, PPV or NPV of EndoBRAIN exceeds 90% in distinguishing neoplasm from non-neoplasm in 10 mm or less lesion. 3.Whether either of diagnosis accuracy, sensitivity, specificity, PPV or NPV of EndoBRAIN exceeds 90% in distinguishing neoplasm from non-neoplasm in 5 mm or less lesion. 4.In case of diagnostic confidence is high, whether the negative predictive value for diagnosing 5 mm or less lesions in the rectum and sigmoid colon is more than 90%. 5.In case of diagnostic confidence is high, whether the each of accuracy, sensitivity, specificity, PPV or NPV value for diagnosing colorectal lesion using EndoBRAIN for distinguishing neoplasm from non-neoplasm in 10 mm or less lesion exceeds 90%. 6.In case of diagnostic confidence is high, whether the each of accuracy, sensitivity, specificity, PPV or NPV for diagnosing colorectal lesion using EndoBRAIN for distinguishing neoplasm from non-neoplasm in 5 mm or less lesion exceeds 90%. 7.Time required for diagnosis. 8.Reproducibility in EndoBRAIN diagnosis 9.Verification that EndoBRAIN is superior to non-specialist in results of specificity, PPV and NPV for distinguishing neoplasm from non-neoplasm in colorectal lesion of 10 mm or less. 10.Verification that EndoBRAIN has better diagnostic results than non-specialists in each of accuracy, sensitivity, specificity, PPV, NPV in distinguishing neoplasm from non-neoplasm in colorectal lesion of 5 mm or less. 11.In the case of diagnosis confidence is high, verification that EndoBRAIN has better diagnostic results than non-specialists in each of accuracy, sensitivity, specificity, PPV, NPV of distinguishing neoplasm from non-neoplasm of colorectal lesion of 5 mm or less. *In the secondary outcomes, the diagnostic abilities of both the staining and narrow-band unltra-high magnifying image are each evaluated.

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	30 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Colorectal lesions with a maximum diameter of 10 mm or less which were observed and resected by CF-Y0058I at the digestive desease center of Showa University Northern Yokohama Hospital, and were capable of pathological evaluation. Regarding the use of image data, a case in which written consent was obtained from the patient himself before the endoscopic examination. At the time of endoscopic image photographing, patients who are 30 to 80 years of age. The leision from which white light image, ultra-high magnifying image and ultra-high magnifying NBI images are all acquired.
Key exclusion criteria	Lesions from patients with inflammatory bowel disease(broad sense). Non-epithelial lesion(carcinoid tumor, malignant lymphoma) Sessile serrated adenoma/polyp In case that, each ultra-high magnifying image, ultra-high magnifying NBI and white light image can not be evaluated because of unclear image. Because of strong image artifacts, diagnosis is impossible with EndoBRAIN(output as Not a Good Sample or Low confidence). Lesions with multiple different pathological components within the same lesion.
Target sample size	30000

Research contact person
Name of lead principal investigator	Shin-ei Kudo
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Address	35-1 Chigasaki-chuo, Tsuzuki, Yokohama 224-8503
TEL	045-949-7000
Email	kudos@med.showa-u.ac.jp

Public contact
Name of contact person	Yuichi Mori
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Address	35-1 Chigasaki-chuo, Tsuzuki, Yokohama 224-8503
TEL	045-949-7000
Homepage URL
Email	ibusiginjp@gmail.com

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	Japanese Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 09 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 14 Day
Anticipated trial start date	2017 Year 11 Month 10 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	This study is a retrospective study using a web-based test.

Management information
Registered date	2017 Year 08 Month 26 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032802