Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

September 7, 2013 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47709

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China
        • Beijing ChaoYang Hospital affiliated to the Capital Medical University
      • Beijing, Beijing, China
        • Beijing Hospital affiliated to Ministry of Health
      • Beijing, Beijing, China
        • Chinese 307 Hospital affiliated to the People's Liberation Army
      • Beijing, Beijing, China
        • First Hospital affiliated to Peking University
      • Beijing, Beijing, China
        • The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Beijing, Beijing, China
        • The General Hospital affiliated to Beijing Military Area Command
    • Chongqing
      • Chongqing, Chongqing, China
        • Southwest Hospital affiliated to the Third Military Medical University
    • Guangdong
      • Zhuhai, Guangdong, China
        • Population and Family Planning Service Center of Zhuhai
    • Hebei
      • Qinhuangdao, Hebei, China
        • Maternity & Child Care Center of Qinhangdao
    • Jiangsu
      • Yancheng, Jiangsu, China
        • YingBin Surgery Hospital of Yancheng
    • Shanghai
      • Shanghai, Shanghai, China
        • The Cancer Hospital affiliated to Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China
        • ShanXi Traditional Medicine Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • The Cancer Hospital affiliated to Tianjin Medical University

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

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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
  • males.

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

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group 1
screening with mammography alone
Other: mammography
participants were screened by mammography alone every year
EXPERIMENTAL: group 2
screening with ultrasonography alone
Other: ultrasound
participants were screened by ultrasound alone every year
EXPERIMENTAL: group 3
screening with both mammography and ultrasound
Other: mammography and ultrasound
Participants were screened by both mammography and ultrasound every year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
screening yield
Time Frame: 3 years
Sensitivities, specificities, positive predictive values, and negative predictive values
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 3 years
cost of each screening modility to detect one 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (ESTIMATE)

June 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 7, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-breast-screening

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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