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

July 7, 2020 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Songjie Shen, MD
  • Phone Number: (010) 6915 8721
  • Email: shensj@pumch.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo ultrasound and X-rays

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mammography and ultrasound
mammography and ultrasound screening
Diagnostic test: mammography and ultrasound screening
Patients screened by both mammography and ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
screening yield
Time Frame: 3 years
The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cost-effectiveness
Time Frame: 3 years
The cost-effectiveness of each screening modality to detect one case of breast cancer
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Songjie Shen, MD, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-MUSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual information of each participant of the trials is not shown in public, yet can be obtained upon reasonable requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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