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Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)

Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM) - CD-CONFIRM

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000032298
Enrollment
1400
Registered
2018-04-18
Start date
2018-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Typical simple cyst 2. Lesions which received vacuum-assisted biopsy 3. Masses more than 5 cm in diameter

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTakanori Watanabe

National Hospital Organization Sendai Medical Center Breast Surgery

tak@snh.go.jp022-293-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026