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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039736
Receipt No. R000045319
Scientific Title Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Date of disclosure of the study information 2020/03/08
Last modified on 2020/09/07

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Basic information
Public title Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Acronym Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Scientific Title Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Scientific Title:Acronym Breast screening combined with non-enhanced breast MRI and breast automatic ultrasound.
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Verification of the usefulness of non-enhanced MRI in screening for breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination of non-contrast MRI findings in breast cancer screening.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Comparison of Breast Ultrasound and Non-contrast MRI Findings in Single Breast Screening.
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
18 years-old <=
Age-upper limit
75 years-old >
Gender Female
Key inclusion criteria Documented consent to test plan.
Women who are not pregnant or nursing.
Currently working at this facility.
Key exclusion criteria Pregnant or breastfeeding.
When judged to be inappropriate for participation in this test.
Not working at this facility.
Target sample size 31

Research contact person
Name of lead principal investigator
1st name Shinsaku
Middle name
Last name KANAZAWA
Organization SUNKOKAI social medical corporation KOGA Hospital
Division name Breast Surgery
Zip code 425-0088
Address 2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL 0546285500
Email shikanazawa-gi@umin.net

Public contact
Name of contact person
1st name Shinsaku
Middle name
Last name KANAZAWA
Organization SUNKOKAI social medical corporation KOGA Hospital
Division name Breast Surgery
Zip code 425-0088
Address 2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL 0546285500
Homepage URL
Email shikanazawa-gi@umin.net

Sponsor
Institute SYUNKOKAI social medical corporation KOGA Hospital
Institute
Department

Funding Source
Organization SUNKOKAI social medical corporation KOGA Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization SUNKOKAI social medical corporation KOGA Hospital
Address 2-30-1, Daikakuji, Yaizu-shi, Shizuoka
Tel 0546285500
Email shikanazawa-gi@umin.net

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
2020 Year 03 Month 08 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 45
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 03 Month 04 Day
Date of IRB
2020 Year 03 Month 04 Day
Anticipated trial start date
2020 Year 04 Month 26 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 08 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045319

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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