The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness (MUST-BE)

Soon Chun Hyang University

Status: Unknown

Conditions: Invasive Cancer; Ductal Carcinoma in Situ

Treatments: Device: Digital mammography; Device: Ultrasonography

Study type: Observational

Funder types: Other

Identifiers

NCT02909426

1520200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,880 patients

Sex: Female

Ages: 40 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

11,880 participants in 1 patient group

Women aged 40-59

Description:

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.

Treatment:

Device: Ultrasonography

Device: Digital mammography