UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031430
Receipt number R000035833
Scientific Title Evaluation of ulcerative colitis with deep neural networks based on endoscopic images
Date of disclosure of the study information 2018/03/15
Last modified on 2019/02/25 18:24:06

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Basic information

Public title

Evaluation of ulcerative colitis with deep neural networks based on endoscopic images

Acronym

DNN-UC

Scientific Title

Evaluation of ulcerative colitis with deep neural networks based on endoscopic images

Scientific Title:Acronym

DNN-UC

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to evaluate the varidity of deep neural networks for ulcerative colitis (DNN-UC)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

accuracy of DNN-UC to evaluate endoscopic and histological healing

Key secondary outcomes

i) ability of DNN-UC to score UCEIS
ii) accuracy of DNN-UC for endoscopic and histological healing in each segment
iii) accuracy of DNN-UC in each confidence case
iv) accuracy of DNN-UC stratified with the degree of colon cleaning.


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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

the patients who underwent colonoscopy for evaluation of UC

Key exclusion criteria

i) patients with prior colon surgery, IBD unclassified, Crohns disease, colorectal neoplasia, or concomitant infectious colitis
ii) patients for whom colonoscopy were contraindicated
iii) patients for whom biopsy were contraindicated because of blood disease or antithrombotic or anticoagulation therapy.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Ohtsuka

Organization

Tokyo Medical and Dental University

Division name

Department of Endoscopy

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5877

Email

kohtsuka.gast@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kento Takenaka

Organization

Tokyo Medical and Dental University

Division name

Department of Endoscopy

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5877

Homepage URL


Email

ktakenaka.gast@tmd.ac.jp


Sponsor or person

Institute

Department of Endoscopy, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

the Cooperation Program between Tokyo Medical and Dental University and Sony Imaging Products & Solutions Inc.

Organization

Division

Category of Funding Organization

Other

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

2018 Year 03 Month 15 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

Completed

Date of protocol fixation

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2018 Year 01 Month 15 Day

Date analysis concluded

2018 Year 02 Month 28 Day


Other

Other related information

Perform colonoscopy, capture endoscopic images, and perform biopsy from each 5 segments


Management information

Registered date

2018 Year 02 Month 22 Day

Last modified on

2019 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name