Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)
Not Applicable
Recruiting
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000032298
- Lead Sponsor
- The Japan Society of Ultrasonics in Medicine, Japan Association of Breast and Thyroid Sonology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1400
Inclusion Criteria
Not provided
Exclusion Criteria
1. Typical simple cyst 2. Lesions which received vacuum-assisted biopsy 3. Masses more than 5 cm in diameter
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method 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