UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041463 |
|---|---|
| Receipt number | R000047332 |
| Scientific Title | Research on discrimination accuracy and basis of judgment in breast ultrasound images by CNN |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2020/08/19 11:06:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on discrimination accuracy and basis of judgment in breast ultrasound images by CNN
Acronym
Research on discrimination accuracy and basis of judgment in breast ultrasound images by CNN
Scientific Title
Research on discrimination accuracy and basis of judgment in breast ultrasound images by CNN
Scientific Title:Acronym
Research on discrimination accuracy and basis of judgment in breast ultrasound images by CNN
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Create an algorithm to discriminate between
benign and malignant binary values on the
ultrasonic image of the case where the
breast ultrasonic examination was performed, and examine the discrimination accuracy and the basis of the determination.
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Examine the usefulness of an AI model that distinguishes benign and malignant tumors by calculating sensitivity, specificity, accuracy, and AUC.
Key secondary outcomes
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
Among the cases in the image database* managed by the JABTS Terminology Criteria Committee, those who underwent ultrasound examination from September 2009 to December 2009, breasts from November 2011 to December 2015 Patients who have undergone ultrasound examination and who meet the following
1. A mass lesion has already been recognized.
2. The results of definitive diagnosis or B-mode category judgment are linked.
Key exclusion criteria
1.typical cyst
2.Tumor-forming lesions of 5 cm or more.
3.Previously observed lesions
4.Vacuum-assisted biopsy in another hospital
Target sample size
2613
Research contact person
Name of lead principal investigator
| 1st name | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate school of Medicine
Division name
Bio Statistics
Zip code
980-8574
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 | Takuhiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tohoku University Graduate school of Medicine
Division name
Bio Statistics
Zip code
980-8574
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,Bio Statistics
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MHLW Certified Clinical Research Review Board, Tohoku University
Address
2-1-1 Katahira, Aoba-ku, Sendai, Miyagi
Tel
022-718-0461
office@nrs.hosp.tohoku.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
| 2021 | Year | 03 | Month | 31 | 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
2613
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
| 2020 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 19 | Day |
Last modified on
| 2020 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047332
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
