The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness
- Conditions
- Invasive CancerDuctal Carcinoma in Situ
- Interventions
- Device: UltrasonographyDevice: Digital mammography
- Registration Number
- NCT02909426
- Lead Sponsor
- Soonchunhyang University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 11880
- Women aged 40-59 years
- No history of any cancer
- No breast mammography (and ultrasonography, in case of intervention arm) after the introduction of digital mammography
- Interstitial injection
- Women with history of any cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women aged 40-59 Digital mammography Asymptomatic women aged 40-59 who participate in the National Cancer Screening Program in Korea and agreed with participating in this study will be the cohort. The participants' digital mammography and ultrasonography will be interpreted combinedly by radiologists who perform the screening sonography and the participants' digital mammography will be interpreted independently by other radiologists who do not perform the screening sonography. Women aged 40-59 Ultrasonography Asymptomatic women aged 40-59 who participate in the National Cancer Screening Program in Korea and agreed with participating in this study will be the cohort. The participants' digital mammography and ultrasonography will be interpreted combinedly by radiologists who perform the screening sonography and the participants' digital mammography will be interpreted independently by other radiologists who do not perform the screening sonography.
- Primary Outcome Measures
Name Time Method Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only 1 year after the screening rate of positive results of the screening among histologically proved breast cancer patients
- Secondary Outcome Measures
Name Time Method Cost-utility of supplemental ultrasonography of the breast 1 year after the screening 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).
Cost-effectiveness of supplemental ultrasonography of the breast 1 year after the screening Comparison of the cost for detecting one breast cancer patient by two groups.
Trial Locations
- Locations (1)
Soon Chun Hyang University Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of