UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007605 |
|---|---|
| Receipt number | 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 10:32:45 |
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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
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
Sponsor or person
Institute
Japan Association of Breast and Thyroid Sonology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008715
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
