UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037189 |
|---|---|
| Receipt number | 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 | 2022/06/29 10:45:23 |
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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
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/
radiology@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University, Graduate School of Medicine
Institute
Department
Personal name
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
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1186/s12885-021-08847-9
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s12885-021-08847-9
Number of participants that the trial has enrolled
312
Results
The overall increase in the ratios of sensitivity, specificity, accuracy, PPV, and NPV were 1.22 (1.14-1.30), 1.00 (1.00-1.01), 1.03 (1.02-1.04), 1.07 (1.0-1.11), and 1.02 (1.01-1.03) by using the CAD, respectively.
Results date posted
| 2022 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 312 chest radiographs were collected as a test dataset, including 59 malignant images (59 nodules of lung cancer) and 253 normal images.
Participant flow
The eligibility criteria for the radiographs were as follows: (1) Mass lesions larger than 30 mm in size were excluded. (2) Metastatic lung cancer that was not primary to the lung was excluded. (3) Lung cancers showing anything other than nodular lesions on radiograph were excluded. (4) Nodules in the chest radiographs were annotated with bounding box, referring to chest CT images by two board-certificated radiologists
Adverse events
Nothing
Outcome measures
Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/42391
