Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Breast Cancer

Treatments: Other: mammography; Other: mammography and ultrasound; Other: ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01880853

PUMCH-breast-screening

Details and patient eligibility

About

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.

Enrollment: 47,709 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47,709 participants in 3 patient groups

group 1

Experimental group

Description:

screening with mammography alone

Treatment:

Other: mammography

group 2

Experimental group

Description:

screening with ultrasonography alone

Treatment:

Other: ultrasound

group 3

Experimental group

Description:

screening with both mammography and ultrasound

Treatment:

Other: mammography and ultrasound