The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Breast Cancer Screening in Women Aged 40-59: Digital Mammography With Supplemental Breast Ultrasonography Versus Digital Mammography Only

Conditions
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Invasive Cancer, Ductal Carcinoma in Situ

Intervention / Treatment
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* Device: Ultrasonography
* Device: Digital mammography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women aged 40-59<br>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. | Device: Ultrasonography<br>* Radiologists' hand-held bilateral breast ultrasonography for each participant for one time<br>Device: Digital mammography<br>* Full-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year after the screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of supplemental ultrasonography of the breast | Comparison of the cost for detecting one breast cancer patient by two groups. | 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). | 1 year after the screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Digital mammography, Ultrasonography, Sensitivity, Specificity