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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women aged 40-59 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography | Device | Radiologists' hand-held bilateral breast ultrasonography for each participant for one time |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 40-59 years at target population in National Cancer Screening Program
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| Name | Affiliation | Role |
|---|---|---|
| EUN HYE LEE, MD, Ph.D | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital | Bucheon-si | Gyeonggi-do | 420-767 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26547101 | Background | Ohuchi N, Suzuki A, Sobue T, Kawai M, Yamamoto S, Zheng YF, Shiono YN, Saito H, Kuriyama S, Tohno E, Endo T, Fukao A, Tsuji I, Yamaguchi T, Ohashi Y, Fukuda M, Ishida T; J-START investigator groups. Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for breast cancer in the Japan Strategic Anti-cancer Randomized Trial (J-START): a randomised controlled trial. Lancet. 2016 Jan 23;387(10016):341-348. doi: 10.1016/S0140-6736(15)00774-6. Epub 2015 Nov 5. |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D008327 | Mammography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
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| Digital mammography | Device | Full-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time |
|
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 |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D007154 | Immune System Diseases |