Mammography screening has limited performance in young women or women with dense breasts although it is the only proven method for breast cancer screening that reduces the mortality. The investigators propose a multicenter trial of breast cancer screening to assess the effectiveness of supplemental ultrasonography for Korean women aged 40-59 years.
The investigators will screen same consecutive participants using both methods; digital mammography plus supplemental ultrasonography (intervention arm) and digital mammography only (control arm) for 5 years. The investigators will collect follow-up information by assessment of screening records, questionnaire, and official cancer registry. The primary outcome will be sensitivity, specificity, recall rate, cancer detection rate and stage distribution at the end of first round of screening. The secondary outcome will be cost-effectiveness and cost-utility of digital mammography with ultrasonography versus digital mammography only for breast cancer screening. It is hoped that the results of this trial will provide guidance of effective breast cancer screening strategy to women aged 40-59, especially with dense breasts.
Study Type
OBSERVATIONAL
Enrollment
11,880
Radiologists' hand-held bilateral breast ultrasonography for each participant for one time
Full-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time
Soon Chun Hyang University Hospital
Bucheon-si, Gyeonggi-do, South Korea
Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only
rate of positive results of the screening among histologically proved breast cancer patients
Time frame: 1 year after the screening
Cost-effectiveness of supplemental ultrasonography of the breast
Comparison of the cost for detecting one breast cancer patient by two groups.
Time frame: 1 year after the screening
Cost-utility of supplemental ultrasonography of the breast
Measurement of the incremental cost-utility ratio, which is calculated by dividing the difference in costs by difference in the quality-adjusted life year (QALY).
Time frame: 1 year after the screening
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