UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031548 |
|---|---|
| Receipt number | R000035991 |
| Scientific Title | Computer-aided diagnosis system for breast ultrasound images using deep learning |
| Date of disclosure of the study information | 2018/03/03 |
| Last modified on | 2019/03/04 08:40:38 |
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Basic information
Public title
Computer-aided diagnosis system for breast ultrasound images using deep learning
Acronym
Computer-aided diagnosis system for breast ultrasound images using deep learning
Scientific Title
Computer-aided diagnosis system for breast ultrasound images using deep learning
Scientific Title:Acronym
Computer-aided diagnosis system for breast ultrasound images using deep learning
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Developing the algorithm for deep learning to classify the breast mass as benign or malignant from ultra sound images, and evaluate it's usefulness.
Basic objectives2
Others
Basic objectives -Others
Usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy, sensitivity, specificity and area under the curve of the algorithm which classifying lesion as benign or malignant.
Key secondary outcomes
Accuracy and sensitivity of the algorithm which classifying lesion as 3 categories by.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were within the image database managed by Japan Association of Breast and Thyroid Sonology, and received a breast ultrasound examination from November 2011 to December 2015. And satisfied the following rules.
1.Mass lesions had already been assessed.
2.Associating with definitive diagnosis or category diagnosed by B-mode
Key exclusion criteria
1.Typical cysts
2. Mass lesions >= 4.5cm diameter
Target sample size
1543
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuhiro Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Biostatistics
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7659
yamaguchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuhiro Yamaguchi |
Organization
Tohoku University Graduate School of Medicine
Division name
Biostatistics
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7659
Homepage URL
yamaguchi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Biostatistics
Institute
Department
Personal name
Funding Source
Organization
SAS Institute Japan Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Association of Breast and Thyroid Sonology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect the maximum number of cases that can be collected
Management information
Registered date
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035991
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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