UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038547
Receipt number R000043837
Scientific Title computer-aided diagnostic system for endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis
Date of disclosure of the study information 2019/11/12
Last modified on 2020/06/09 15:02:43

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

computer-aided diagnostic system for
endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis

Acronym

EndoBRAIN-UC STUDY

Scientific Title

computer-aided diagnostic system for
endocytoscopic image in predicttion of imflamatory activity of patients with ulcerative colitis

Scientific Title:Acronym

EndoBRAIN-UC STUDY

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of computer-aided diagnosis software(EB-03) using colonoscopy still image database.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The accuracy of computer-aided diagnosis software(EB-03) for the presence of histological
inflammation (Geboes score 3.1 or more)

Key secondary outcomes

The sensitivity of computer-aided diagnosis software(EB-03) for the presence of histological inflammation (Geboes score 3.1 or more)

The specificity of computer-aided diagnosis software(EB-03) for the presence of histological inflammation (Geboes score 3.1 or more)


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Pts with ulcerative colitis who were underwent with endocytoscopy at Showa University Yokohama Northern Hospital between October 2016 and December 2017.

2)Pts with informed consent.

Key exclusion criteria

1)Pts whose examination video is not saved.

Target sample size

40


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

Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama

TEL

045-949-7000

Email

kudos@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Yasuharu
Middle name
Last name Maeda

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

Chigasaki-chuo 35-1, Tsuduki-ku, Yokohama

TEL

045-949-7468

Homepage URL


Email

yasuharumaeda610@hotmail.com


Sponsor or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRB in Showa University Northern Yokohama Hospital

Address

Chigasaki-chuo 35-1, Tsuduki-ku, 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 11 Month 12 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

42

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

Completed

Date of protocol fixation

2019 Year 08 Month 04 Day

Date of IRB

2019 Year 08 Month 15 Day

Anticipated trial start date

2019 Year 08 Month 15 Day

Last follow-up date

2019 Year 11 Month 15 Day

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 still image data base.


Management information

Registered date

2019 Year 11 Month 11 Day

Last modified on

2020 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043837


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name