The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

11880 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-02

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Invasive Cancer Ductal Carcinoma in Situ

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ultrasonography

Intervention Type DEVICE

Radiologists' hand-held bilateral breast ultrasonography for each participant for one time

Digital mammography

Intervention Type 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

Interventions

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Ultrasonography

Radiologists' hand-held bilateral breast ultrasonography for each participant for one time

Intervention Type 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

Intervention Type DEVICE

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