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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | lung nodule | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 320 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
radiology@med.osaka-cu.ac.jp |
Public contact | |||||||
Name of contact person |
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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/ | ||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |