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Clinical Trials/NCT04429269
NCT04429269
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Not Applicable

A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis

Peking Union Medical College Hospital1 site in 1 country6,000 target enrollmentJune 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Diagnosis
Sponsor
Peking Union Medical College Hospital
Enrollment
6000
Locations
1
Primary Endpoint
screening yield
Last Updated
5 years ago

Overview

Brief Summary

Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Detailed Description

Breast cancer has become the most common malignancy in women. Improving the early diagnosis of breast cancer can reduce mortality. Mammography is recommended as the main tool for screening and early diagnosis of breast cancer in the guidelines of European and American countries. However, the characteristics of dense breast and young onset of disease in Chinese women make the screening and early diagnosis strategies of Western countries, which are mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Registry
clinicaltrials.gov
Start Date
June 12, 2020
End Date
June 1, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray

Exclusion Criteria

  • Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients

Outcomes

Primary Outcomes

screening yield

Time Frame: 3 years

The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.

Secondary Outcomes

  • cost-effectiveness(3 years)

Study Sites (1)

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