UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031333
Receipt number R000035639
Scientific Title Construction of diagnostic support system using artificial intelligence by community collaboration, medical and engineering cooperation
Date of disclosure of the study information 2018/02/19
Last modified on 2021/02/18 11:32:29

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Basic information

Public title

Construction of diagnostic support system using artificial intelligence by community collaboration, medical and engineering cooperation

Acronym

Construction of diagnostic support system with artificial intelligence by community and medical engineering collaboration

Scientific Title

Construction of diagnostic support system using artificial intelligence by community collaboration, medical and engineering cooperation

Scientific Title:Acronym

Construction of diagnostic support system with artificial intelligence by community and medical engineering collaboration

Region

Japan


Condition

Condition

Malignant tumor

Classification by specialty

Radiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We aim to develop a simple and more accurate diagnosis support system by applying Deep Learning method of artificial intelligence Convolution Neural Network (CNN) to image and patient information.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

accuracy

Key secondary outcomes

Specificity
Sensitivity
Agreement of abnormal lesion


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

The case that performed CT, MRI, radioisotope examination by inspection about iamge diagnosis from December 1, 2012 to November 30, 2017 for the past 5 years in the medical facilities of the coworker, and performed normalcy and an abnormality definitive diagnosis.

Key exclusion criteria

The case that do not save with DICOM format.

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Kikuchi

Organization

Hokkaido University of Science

Division name

Department of Radiological Technology Faculty of Health Sciences,

Zip code

0068585

Address

Maeda 7-15-4-1, Teina, Sapporo, Hokkaido

TEL

09087050691

Email

kikuchi-a@hus.ac.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Kikuchi

Organization

Hokkaido University of Science

Division name

Department of Radiological Technology Faculty of Health Sciences,

Zip code

0068585

Address

Maeda 7-15-4-1, Teina, Sapporo, Hokkaido

TEL

09087050691

Homepage URL


Email

kikuchi-a@hus.ac.jp


Sponsor or person

Institute

Hokkaido University of Science

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University of Science

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

Hokkaido University of Science

Address

Maeda 7-15-4-1, Teina, Sapporo, Hokkaido

Tel

011-688-2382

Email

kikuchi-a@hus.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2017-1

Org. issuing International ID_1

Hokkaido Ono Memorial Hospital

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 02 Month 19 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

Enrolling by invitation

Date of protocol fixation

2018 Year 02 Month 13 Day

Date of IRB

2018 Year 02 Month 18 Day

Anticipated trial start date

2018 Year 02 Month 19 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Even if it does not reach the target registration number, it will end at that point.


Management information

Registered date

2018 Year 02 Month 16 Day

Last modified on

2021 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035639


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name