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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

47,709

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline

Completed

Started Nov 2008

Typical duration for not_applicable breast-cancer

Geographic Reach

1 country

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

Study Start

First participant enrolled

November 1, 2008

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed

Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

3.1 years

First QC Date

June 14, 2013

Last Update Submit

September 7, 2013

Conditions

Breast Cancer

Keywords

breast cancerscreeningmammographyultrasound

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Cost-effectiveness
3 years

Study Arms (3)

group 1

EXPERIMENTAL

screening with mammography alone

Other: mammography

group 2

EXPERIMENTAL

screening with ultrasonography alone

Other: ultrasound

group 3

EXPERIMENTAL

screening with both mammography and ultrasound

Other: mammography and ultrasound

Interventions

mammographyOTHER

participants were screened by mammography alone every year

group 1

ultrasoundOTHER

participants were screened by ultrasound alone every year

group 2

mammography and ultrasoundOTHER

Participants were screened by both mammography and ultrasound every year

group 3

Eligibility Criteria

Age30 Years - 65 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent；
residence from community or working units

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Union Medical College Hospitallead

Study Sites (14)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing ChaoYang Hospital affiliated to the Capital Medical University