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

• Conditions: Breast Cancer Diagnosis; Breast Cancer Screening
• Interventions: Diagnostic Test: mammography and ultrasound screening

• Registration Number: NCT04429269
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study Start: 2020-06-12
• Study First Posted: 2020-06-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 6000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mammography and ultrasound	mammography and ultrasound screening	mammography and ultrasound screening

Primary Outcome Measures

Name	Time	Method
screening yield	3 years	The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.

Secondary Outcome Measures

Name	Time	Method
cost-effectiveness	3 years	The cost-effectiveness of each screening modality to detect one case of breast cancer

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China