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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Shen Songjie, MD
  • Phone Number: 86-010-69152701
  • Email: pumcssj@163.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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