Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Peking Union Medical College Hospital47,709 enrolled

Overview

Early detection of breast cancer through screening has been a common practice in the United States and several European countries for decades.It is effective in reducing the mortality of breast cancer and improving the postoperative quality of life of patients. Mammography has been the standard imaging method for the screening, and in recent years, a supplemental ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed to define an optimal screening strategy that suits Chinese women and the socioeconomics of China.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

47,709

Conditions

Breast Cancer

Interventions

mammographyOTHER

participants were screened by mammography alone every year

ultrasoundOTHER

participants were screened by ultrasound alone every year

mammography and ultrasoundOTHER

Participants were screened by both mammography and ultrasound every year

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent； * residence from community or working units Exclusion Criteria: * pregnancy； * lactation； * known metastatic cancer； * signs or symptoms of breast disease； * presence of breast implants, breast surgery within prior 12 months； * had mammography or ultrasound exam within prior 12 months * males.

Locations (14)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing ChaoYang Hospital affiliated to the Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

screening yield

Sensitivities, specificities, positive predictive values, and negative predictive values

Time frame: 3 years

Secondary Outcomes

Cost-effectiveness

cost of each screening modility to detect one cancer

Time frame: 3 years

Data from ClinicalTrials.gov

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