Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: mammography and ultrasound; Other: mammography; Other: ultrasound

• Registration Number: NCT01880853
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-19
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-07
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47709

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: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 3	mammography and ultrasound	screening with both mammography and ultrasound
group 1	mammography	screening with mammography alone
group 2	ultrasound	screening with ultrasonography alone

Primary Outcome Measures

Name	Time	Method
screening yield	3 years	Sensitivities, specificities, positive predictive values, and negative predictive values

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	3 years	cost of each screening modility to detect one cancer

Trial Locations

Locations (14)

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

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

Chinese 307 Hospital affiliated to the People's Liberation Army; 🇨🇳 Beijing, Beijing, China

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

The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Population and Family Planning Service Center of Zhuhai; 🇨🇳 Zhuhai, Guangdong, China

Maternity & Child Care Center of Qinhangdao; 🇨🇳 Qinhuangdao, Hebei, China

YingBin Surgery Hospital of Yancheng; 🇨🇳 Yancheng, Jiangsu, China

The General Hospital affiliated to Beijing Military Area Command; 🇨🇳 Beijing, Beijing, China

The Cancer Hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China

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

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

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

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