Clinical trial NCT01880853: Ultrasound and Mammography for Screening Breast Cancer in Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
screening
mammography
ultrasound
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 47709
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: screening yield
timeFrame: 3 years
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing ChaoYang Hospital affiliated to the Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital affiliated to Ministry of Health
state: Beijing
city: Beijing
country: China
facility: Chinese 307 Hospital affiliated to the People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: First Hospital affiliated to Peking University
state: Beijing
city: Beijing
country: China
facility: The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: The General Hospital affiliated to Beijing Military Area Command
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital affiliated to the Third Military Medical University
state: Chongqing
city: Zhuhai
country: China
facility: Population and Family Planning Service Center of Zhuhai
state: Guangdong
city: Qinhuangdao
country: China
facility: Maternity & Child Care Center of Qinhangdao
state: Hebei
city: Yancheng
country: China
facility: YingBin Surgery Hospital of Yancheng
state: Jiangsu
city: Shanghai
country: China
facility: The Cancer Hospital affiliated to Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: ShanXi Traditional Medicine Hospital
state: Shanxi
city: Tianjin
country: China
facility: The Cancer Hospital affiliated to Tianjin Medical University
state: Tianjin
Study officials:
affiliation: PUMCH
name: Sun Qiang, MD
role: STUDY_CHAIR
References:
citation: Shen S, Zhou Y, Xu Y, Zhang B, Duan X, Huang R, Li B, Shi Y, Shao Z, Liao H, Jiang J, Shen N, Zhang J, Yu C, Jiang H, Li S, Han S, Ma J, Sun Q. A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women. Br J Cancer. 2015 Mar 17;112(6):998-1004. doi: 10.1038/bjc.2015.33.