NCT02909426

The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 11,880 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Invasive Cancer
• Ductal Carcinoma in Situ

Interventions

Type	Name	Description
DEVICE	Ultrasonography	Radiologists' hand-held bilateral breast ultrasonography for each participant for one time
DEVICE	Digital 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

Timeline

• Start date: 2016-05-02
• Primary completion: 2020-12-31
• Completion: 2023-12-31
• First posted: 2016-09-21
• Last updated: 2021-10-07

Locations

1 site across 1 country: South Korea