UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule
Acronym	Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule
Scientific Title	Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule
Scientific Title:Acronym	Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule
Region	Japan

Condition
Condition	lung nodule
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Validation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ROC analysis, AUC
Key secondary outcomes	Sensitivity, Specificity, Ratio of false positive and Ratio of false negative.

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	1) Patient who can be taken normal exams. 2) The resolution is bigger than 1750 x 1750 pixels.
Key exclusion criteria	1) No significant artifact or objects such as electrocardiograph. 2) Wrong/broken DICOM format. 3) The nodule size is less than 5mm or bigger than 30mm. 4) Diffused. 5) Other than circular shape. 6) Overlapped with organs. 7) Principal investigator determine as improper data.
Target sample size	320

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Yamamoto
Organization	Osaka City University, Graduate School of Medicine
Division name	Department of Diagnostic and Interventional Radiology
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-3831
Email	radiology@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Daiju Middle name Last name Ueda
Organization	Osaka City University, Graduate School of Medicine
Division name	Department of Diagnostic and Interventional Radiology
Zip code	545-8585
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-3831
Homepage URL	http://ocu-radiology.jp/page-1392/
Email	radiology@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University, Graduate School of Medicine
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	Osaka City University School of Medicine / University Hospital Management Office
Address	1-2-7-601, Asahi-machi, Abeno-ku, Osaka
Tel	06-6645-3456
Email	ethics@med.osaka-cu.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 08 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	2019 Year 06 Month 08 Day
Date of IRB	2019 Year 06 Month 27 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	multicenter, prospective observational study

Management information
Registered date	2019 Year 06 Month 27 Day
Last modified on	2019 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042391

Research Plan
Registered date	File name
2020/06/29	Plan.docx

Research case data specifications
Registered date	File name
2020/06/29	The data specification.docx

Research case data
Registered date	File name
2020/06/29	last_results.csv

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