UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028843
Receipt number R000032802
Scientific Title Multicenter validation study on computer-aided diagnostic system for endocytoscopic image in diagnosis of colrectal lesions
Date of disclosure of the study information 2017/09/04
Last modified on 2017/11/10 18:29:51

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Basic information

Public title

Multicenter validation study on computer-aided diagnostic system for
endocytoscopic image in diagnosis of colrectal lesions

Acronym

EndoBRAIN STUDY

Scientific Title

Multicenter validation study on computer-aided diagnostic system for
endocytoscopic image in diagnosis of colrectal lesions

Scientific Title:Acronym

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

1st name
Middle name
Last name Shin-ei Kudo

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


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

1st name
Middle name
Last name Yuichi Mori

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code


Address

35-1 Chigasaki-chuo, Tsuzuki, Yokohama 224-8503

TEL

045-949-7000

Homepage URL


Email

ibusiginjp@gmail.com


Sponsor or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



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)



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

2017 Year 09 Month 04 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

2017 Year 08 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032802


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name