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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007605
Receipt No. R000008715
Scientific Title Multicenter prospective study to evaluate the usefulness of color Doppler ultrasound for breast masses / JABTS BC-04
Date of disclosure of the study information 2012/03/29
Last modified on 2016/03/29

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Basic information
Public title Multicenter prospective study to evaluate the usefulness of color Doppler ultrasound for breast masses / JABTS BC-04
Acronym JABTS BC-04
Scientific Title Multicenter prospective study to evaluate the usefulness of color Doppler ultrasound for breast masses / JABTS BC-04
Scientific Title:Acronym JABTS BC-04
Region
Japan

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

Objectives
Narrative objectives1 To develop and evaluate the ultrasound diagnosis system including color doppler for breast mass.
Basic objectives2 Others
Basic objectives -Others Usefulness
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity,specificity and area under the curve of the new diagnosis sysytem in comparison with converntional B-mode only system.
Key secondary outcomes 1.Factors affecting the sensitivity and/or specificity of the new diagnosis system.
2.Changes of doctor's confidence at diagnosis by adding color doppler.
3.Condition of color doppler.
4.Changes of sensitivity and specificity combined with elastography.

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 Patient with mass lesions assessed by breast ultrasound and pathology examination.
Key exclusion criteria 1.Typical cysts.
2.Mass lesions diagnosed before this study and followed thereafter.
3.Mass lesions with vacuum-assisted biopsy at other institution.
4.Mass lesions >= 5cm diameter.
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Watanabe
Organization Sendai Medical Center , National Hospital Organization
Division name Breast Surgery
Zip code
Address 2-8-8 Miyagino,Miyagino-ku,Sendai,Miyagi 983-8520,Japan
TEL 022-293-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Sendai Medical Center , National Hospital Organization
Division name Breast Surgery
Zip code
Address 2-8-8 Miyagino,Miyagino-ku,Sendai,Miyagi 983-8520,Japan
TEL
Homepage URL
Email

Sponsor
Institute Japan Association of Breast and Thyroid Sonology
Institute
Department

Funding Source
Organization Japan Association of Breast and Thyroid Sonology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 仙台医療センター(宮城県)、兵庫県立がんセンター(兵庫県)、東京都予防医学協会保健会館クリニック(東京都)、西神戸医療センター(兵庫県)、栃木県立がんセンター(栃木県)、国立国際医療研究センター(東京都)、筑波メディカルセンター(茨城県)、東邦大学医療センター大森病院(東京都)、獨協医科大学病院(栃木県)、自治医科大学附属さいたま医療センター(埼玉県)、守谷慶友病院(茨城県)、聖路加国際病院(東京都)、南大阪病院(大阪府)、立花病院(兵庫県)、りんくう総合医療センター(大阪府)、昭和大学(東京都)、高松平和病院(香川県)、京都ブレストセンター沢井記念乳腺クリニック(京都府)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 29 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
2011 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To create a standard judgment of a color doppler method of a breast tumor ultrasound diagnostic and to know that usefulness

Management information
Registered date
2012 Year 03 Month 29 Day
Last modified on
2016 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008715

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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