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Clinical Trials/NCT01880853
NCT01880853
Completed
Not Applicable

Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Peking Union Medical College Hospital14 sites in 1 country47,709 target enrollmentNovember 2008
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Peking Union Medical College Hospital
Enrollment
47709
Locations
14
Primary Endpoint
screening yield
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
December 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

screening yield

Time Frame: 3 years

Sensitivities, specificities, positive predictive values, and negative predictive values

Secondary Outcomes

  • Cost-effectiveness(3 years)

Study Sites (14)

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