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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032298
Receipt No. R000036829
Scientific Title Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)
Date of disclosure of the study information 2018/04/18
Last modified on 2018/04/18

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Basic information
Public title Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)
Acronym CD-CONFIRM
Scientific Title Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)
Scientific Title:Acronym CD-CONFIRM
Region
Japan

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

Objectives
Narrative objectives1 We developed a draft of color Doppler diagnostic criteria for breast masses by JABTS BC-04 study. In this study, we will study the usefulness of the color Doppler criteria. Furthermore, we will study the usefulness of elastography for breast masses in benign/malignant diagnosis. If possible, we will study about color Doppler diagnostic criteria for complex cystic and solid masses.
Basic objectives2 Others
Basic objectives -Others Usefulness
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Sensitivity, specificity and accuracy of the B-mode alone, and the combination of color Doppler and B-mode.
2. Examination of usefulness of each finding of the color Doppler ultrasound in benign/malignant diagnosis (univariate analysis and multivariate analysis).
Key secondary outcomes 1. Sensitivity, specificity and accuracy of the B-mode alone, and the combination of color Doppler, B-mode and elastography.
2. Impact of age factor on the sensitivity and/or specificity of the new diagnosis system
3. Reproducibility of evaluators

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 1. Lesions recognized as a mass on breast ultrasonography (including complex cystic and solid masses)
2. Digital video clips of color Doppler method are available
3. Pathologically confirmed masses
4. Even masses without pathological confirmation can be registered as benign masses if it is confirmed that there was no change for more than one year on the B-mode ultrasound
Key exclusion criteria 1. Typical simple cyst
2. Lesions which received vacuum-assisted biopsy
3. Masses more than 5 cm in diameter
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Watanabe
Organization National Hospital Organization Sendai Medical Center
Division name Breast Surgery
Zip code
Address 2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi 983-8520, Japan
TEL 022-293-1111
Email tak@snh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Watanabe
Organization National Hospital Organization Sendai Medical Center
Division name Breast Surgery
Zip code
Address 2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi 983-8520, Japan
TEL 022-293-1111
Homepage URL
Email tak@snh.go.jp

Sponsor
Institute The Japan Society of Ultrasonics in Medicine, Japan Association of Breast and Thyroid Sonology
Institute
Department

Funding Source
Organization The Japan Society of Ultrasonics in Medicine, Japan Association of Breast and Thyroid Sonology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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 国立病院機構 仙台医療センター
医療法人慶友会守谷慶友病院
吹田徳洲会病院
南大阪病院外科
公益財団法人東京都予防医学協会
兵庫県立がんセンター
糸島医師会病院
獨協医科大学病院
神戸市立西神戸医療センター
国立病院機構大阪医療センター
とくしまブレストケアクリニック
香川医療生活協同組合高松平和病院
社会医療法人博愛会相良病院
札幌ことに乳腺クリニック
北海道大学病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 18 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Collected ultrasound images of the subjects will be evaluated by independent Centralized Image Interpretation Committee using the draft of color Doppler diagnostic criteria.

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2018 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036829

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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