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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037189
Receipt No. R000042391
Scientific Title Evaluation of Computer-Assisted-Detection (CAD) software for Chest X-ray lung Nodule
Date of disclosure of the study information 2019/08/01
Last modified on 2019/11/12

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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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