Ultrasound-based Breast Cancer Screening in Chinese Women

October 15, 2014 updated by: Qiang SUN, Peking Union Medical College Hospital
In the present study, the investigators will screen breast cancer of the Chinese women based on ultrasound and aim to compare the risk evaluation model of PUMCH model which was established by our previous work with other risk models.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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, however, our previous study has shown that ultrasound is more sensitive and less expensive than mammography. In the present study, the investigators will screen breast cancer of the Chinese women based on ultrasound and aim to evaluate the risk model (PUMCH model) which was established by our previous work.

Study Type

Observational

Enrollment (Anticipated)

20000

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
      • Chifeng, China
        • Recruiting
        • Chifeng Baoshan Hospital
        • Contact:
          • Yaping Li, MD
        • Principal Investigator:
          • Yaping Li, MD
      • Chongqing, China
        • Recruiting
        • First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Guosheng Ren, MD
        • Principal Investigator:
          • Guosheng Ren, MD
      • Mengzi, China
        • Recruiting
        • First People's Hospital of Honghe State
        • Contact:
          • Fengming Xie, MD
        • Principal Investigator:
          • Fengming Xie, MD
      • Ordos, China
        • Recruiting
        • Ordos Central Hospital
        • Contact:
          • Zhendong Wang, MD
        • Principal Investigator:
          • Zhendong Wang, MD
      • Qingdao, China
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
          • Mei Sun, MD
        • Principal Investigator:
          • Mei Sun, MD
      • Shenyang, China
        • Recruiting
        • First Affiliated Hospital of China Medical University
        • Principal Investigator:
          • Feng Jin, MD
      • Wulumuqi, China
        • Recruiting
        • Hospital of Xinjiang Production and Construction Corps
        • Contact:
          • Shuanghu Yuan, MD
        • Principal Investigator:
          • Shuanghu Yuan, MD
      • Xingtai, China
        • Recruiting
        • Third Hospital of Xingtai
        • Contact:
          • Jingjing Yu, MD
        • Principal Investigator:
          • Jingjing Yu, MD
      • Yingshan, China
        • Recruiting
        • Yingshan Maternal and Child Health Hospital
        • Contact:
          • Yue Chen, MD
        • Principal Investigator:
          • Yue Chen, MD
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
          • Shen Songjie, Doctor
          • Phone Number: 86-010-69152701
          • Email: pumcssj@163.com
        • Principal Investigator:
          • Sun Qiang, Doctor
      • Beijing, Beijing, China
        • Recruiting
        • Beijing ChaoYang Hospital affiliated to the Capital Medical University
        • Contact:
          • Hongchuan Jiang, MD
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Hospital affiliated to Ministry of Health
        • Contact:
          • Bo Li, MD
        • Principal Investigator:
          • Bo Li, MD
      • Beijing, Beijing, China
        • Recruiting
        • First Hospital affiliated to Peking University
        • Contact:
          • Yinhua Liu, MD
        • Principal Investigator:
          • Yinhua Liu, MD
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Southwest Hospital affiliated to the Third Military Medical University
        • Principal Investigator:
          • Jun Jiang, MD
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • ShanXi Traditional Medicine Hospital
        • Contact:
          • Yue Shi, MD
        • Principal Investigator:
          • Yue Shi, MD
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • The Cancer Hospital affiliated to Tianjin Medical University
        • Contact:
          • Jin Zhang, MD
        • Principal Investigator:
          • Jin Zhang, MD

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

healthy women without breast-related symptoms

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
ultrasound plus clinical breast examination
Other: ultrasound plus clinical breast examination
all the participants will be required to fill risk factor questionaires and then be screened with ultrasound plus physical examination every year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of cancer detected in the high-risk group
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-breast-screening 2

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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