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NCT04429269 Clinical Trial

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

Breast Cancer Screening Clinical Trial

— MUSD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04429269
Other study ID # PUMCH-MUSD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 12, 2020
Est. completion date June 1, 2023

Study information
Verified date July 2020
Source Peking Union Medical College Hospital
Contact Songjie Shen, MD
Phone (010) 6915 8721
Email shensj@pumch.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 6000
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers
Gender Female
Age group 35 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• mammography and ultrasound screening
Patients screened by both mammography and ultrasound.

Locations
Country Name City State
China Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Beijing

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 screening yield The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods. 3 years
Secondary cost-effectiveness The cost-effectiveness of each screening modality to detect one case of breast cancer 3 years
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