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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041463
Receipt No. 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

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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
Email 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
Email yamaguchi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate school of Medicine,Bio Statistics
Institute
Department

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
Email 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
URL(English) https://upload.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


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