Clinical trial NCT02268643: Ultrasound-based Breast Cancer Screening in Chinese Women
Official title: Ultrasound-based Breast Cancer Screening in Chinese Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
screening
ultrasound
risk model
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 20000
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy women without breast-related symptoms

Brief summary: In the present study, the investigators will screen breast cancer of the Chinese women based on ultrasound and aim to compare the risk evaluation model of PUMCH model which was established by our previous work with other risk models.

Detailed description: 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, however, our previous study has shown that ultrasound is more sensitive and less expensive than mammography. In the present study, the investigators will screen breast cancer of the Chinese women based on ultrasound and aim to evaluate the risk model (PUMCH model) which was established by our previous work.

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: number of cancer detected in the high-risk group
timeFrame: 3 years
Secondary outcomes:
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: First Hospital affiliated to Peking University
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital affiliated to the Third Military Medical University
state: Chongqing
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
city: Chifeng
country: China
facility: Chifeng Baoshan Hospital
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
city: Mengzi
country: China
facility: First People's Hospital of Honghe State
city: Ordos
country: China
facility: Ordos Central Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shenyang
country: China
facility: First Affiliated Hospital of China Medical University
city: Wulumuqi
country: China
facility: Hospital of Xinjiang Production and Construction Corps
city: Xingtai
country: China
facility: Third Hospital of Xingtai
city: Yingshan
country: China
facility: Yingshan Maternal and Child Health Hospital
Study officials:
affiliation: PUMCH
name: Sun Qiang, MD
role: STUDY_CHAIR
References: