Invasive Cancer, Ductal Carcinoma in Situ
Conditions
Keywords
Screening, Digital mammography, Ultrasonography, Sensitivity, Specificity
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.
Interventions
DEVICEUltrasonography
Radiologists' hand-held bilateral breast ultrasonography for each participant for one time
DEVICEDigital mammography
Full-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time
Sponsors
Ministry of Health & Welfare, Korea
Soonchunhyang University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Interstitial injection * Women with history of any cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
South Korea
Outcome results
None listed