UMIN-CTR Clinical Trial

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
Institute	Hokkaido University of Science
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035639