Ultrasound-based Breast Cancer Screening in Chinese Women

• Conditions: Breast Cancer
• Interventions: Other: ultrasound plus clinical breast examination

• Registration Number: NCT02268643
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-09-29
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-15
• Last Update Submitted: 2014-10-15
• Study First Posted: 2014-10-20
• Last Update Posted: 2014-10-20
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	ultrasound plus clinical breast examination	ultrasound plus clinical breast examination

Primary Outcome Measures

Name	Time	Method
number of cancer detected in the high-risk group	3 years

Trial Locations

Locations (16)

ShanXi Traditional Medicine Hospital; 🇨🇳 Taiyuan, Shanxi, China

Beijing Hospital affiliated to Ministry of Health; 🇨🇳 Beijing, Beijing, China

First Hospital affiliated to Peking University; 🇨🇳 Beijing, Beijing, China

Southwest Hospital affiliated to the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Hospital of Xinjiang Production and Construction Corps; 🇨🇳 Wulumuqi, China

First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

The Cancer Hospital affiliated to Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China

Chifeng Baoshan Hospital; 🇨🇳 Chifeng, China

Beijing ChaoYang Hospital affiliated to the Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Ordos Central Hospital; 🇨🇳 Ordos, China

First People's Hospital of Honghe State; 🇨🇳 Mengzi, China

Yingshan Maternal and Child Health Hospital; 🇨🇳 Yingshan, China

Third Hospital of Xingtai; 🇨🇳 Xingtai, China

Qingdao Municipal Hospital; 🇨🇳 Qingdao, China

First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, China