UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Acronym	Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Scientific Title	Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Scientific Title:Acronym	Evaluation of precision diagnosis using artificial intelligence (AI) diagnostic software for chest X-ray: For practical use in medical and health care for lung cancer treatment
Region	Japan

Condition
Condition	Respiratory disease
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Improvement and evaluation of medical imaging analysis software - EIRL X-Ray Lung nod
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Regarding to Ministry of Health, Labour and Welfare recommending "the process index in the lung cancer examination", we aim recall rate 3% or less, lung cancer discovery rate 0.03% or more, and Positive Predictive Value 1.3% or more
Key secondary outcomes

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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The case that a normal X-rays diagnosis can enforce The image that 1750x1750 pixel is more than it in resolution of the X-rays image which I used for shooting
Key exclusion criteria	The image that image quality and a shooting condition have a problem It is the image with the defect in DICOM information The image which a manager for study studied it and judged to be inappropriate
Target sample size	31000

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Hirano
Organization	Todachuo Healthcare Center
Division name	Healthcare Center
Zip code	335-0022
Address	2-32-20, Kamitoda, Toda, Saitama
TEL	048-442-1118
Email	t_hirano@tmg.or.jp

Public contact
Name of contact person	1st name Hisashi Middle name Last name Saji
Organization	St. Marianna University School of Medicine
Division name	Chest Surgery
Zip code	2168511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL	044-977-8111
Homepage URL
Email	saji-q@ya2.so-net.ne.jp

Sponsor
Institute	lpixel inc.
Institute
Department

Funding Source
Organization	lpixel inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Todachuo General Hospital
Address	1-19-3, Honmachi, Toda, Saitama
Tel	0570-01-1114
Email	t_hirano@tmg.or.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	2022 Year 11 Month 01 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	2021 Year 10 Month 08 Day
Date of IRB	2021 Year 10 Month 27 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2025 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing

Management information
Registered date	2022 Year 10 Month 13 Day
Last modified on	2022 Year 10 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056028