Ultrasound-based Breast Cancer Screening in Chinese Women

Breast Cancer Clinical Trial

Official title:

Ultrasound-based Breast Cancer Screening in Chinese Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02268643
• Other study ID #: PUMCH-breast-screening 2
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2014
• Last updated: October 15, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2014
• Source: Peking Union Medical College Hospital
• Contact: Sun Qiang, MD
• Phone: 86-010-69152701
• Email: sunqiangpumc[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 75 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• ultrasound plus clinical breast examination
all the participants will be required to fill risk factor questionaires and then be screened with ultrasound plus physical examination 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	First Hospital affiliated to Peking University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Chifeng Baoshan Hospital	Chifeng
China	First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Southwest Hospital affiliated to the Third Military Medical University	Chongqing	Chongqing
China	First People's Hospital of Honghe State	Mengzi
China	Ordos Central Hospital	Ordos
China	Qingdao Municipal Hospital	Qingdao
China	First Affiliated Hospital of China Medical University	Shenyang
China	ShanXi Traditional Medicine Hospital	Taiyuan	Shanxi
China	The Cancer Hospital affiliated to Tianjin Medical University	Tianjin	Tianjin
China	Hospital of Xinjiang Production and Construction Corps	Wulumuqi
China	Third Hospital of Xingtai	Xingtai
China	Yingshan Maternal and Child Health Hospital	Yingshan

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	number of cancer detected in the high-risk group		3 years	No