Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880853
• Other study ID #: PUMCH-breast-screening
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: September 7, 2013
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47709
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• mammography
participants were screened by mammography alone every year
• ultrasound
participants were screened by ultrasound alone every year
• mammography and ultrasound
Participants were screened by both mammography and ultrasound every year

Locations

Country	Name	City	State
China	Beijing ChaoYang Hospital affiliated to the Capital Medical University	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	Peking Union Medical College Hospital	Beijing	Beijing
China	The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The General Hospital affiliated to Beijing Military Area Command	Beijing	Beijing
China	Southwest Hospital affiliated to the Third Military Medical University	Chongqing	Chongqing
China	Maternity & Child Care Center of Qinhangdao	Qinhuangdao	Hebei
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	YingBin Surgery Hospital of Yancheng	Yancheng	Jiangsu
China	Population and Family Planning Service Center of Zhuhai	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screening yield	Sensitivities, specificities, positive predictive values, and negative predictive values	3 years	No
Secondary	Cost-effectiveness	cost of each screening modility to detect one cancer	3 years	No