Breast CancerNCT02268643
Ultrasound-based Breast Cancer Screening in Chinese Women
An observational study of Breast Cancer, run by Peking Union Medical College Hospital at 16 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ultrasound plus clinical breast examination
- How many people
- 20,000 participants
- Where
- 16 sitesChina
- Study dates
- Jan 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy women without breast-related symptoms
Who may be able to join
- Written informed consent；
- residence from community or working units
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Sun Qiang, Doctor, 86-010-69152701, sunqiangpumc@163.com
Shen Songjie, Doctor, 86-010-69152701, pumcssj@163.com
- Recruiting
Beijing ChaoYang Hospital affiliated to the Capital Medical University
Beijing, Beijing Municipality
Hongchuan Jiang, MD
Hongchuan Jiang, MD
- Recruiting
Beijing Hospital affiliated to Ministry of Health
Beijing, Beijing Municipality
Bo Li, MD
Bo Li, MD
- Recruiting
First Hospital affiliated to Peking University
Beijing, Beijing Municipality
Yinhua Liu, MD
Yinhua Liu, MD
- Recruiting
Chifeng Baoshan Hospital
Chifeng
Yaping Li, MD
Yaping Li, MD
- Recruiting
Southwest Hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality
Jun Jiang, MD
Jun Jiang, MD
- Recruiting
First Affiliated Hospital of Chongqing Medical University
Chongqing
Guosheng Ren, MD
Guosheng Ren, MD
- Recruiting
First People's Hospital of Honghe State
Mengzi
Fengming Xie, MD
Fengming Xie, MD
- Recruiting
Ordos Central Hospital
Ordos
Zhendong Wang, MD
Zhendong Wang, MD
- Recruiting
Qingdao Municipal Hospital
Qingdao
Mei Sun, MD
Mei Sun, MD
- Recruiting
First Affiliated Hospital of China Medical University
Shenyang
Feng Jin, MD
Feng Jin, MD
- Recruiting
ShanXi Traditional Medicine Hospital
Taiyuan, Shanxi
Yue Shi, MD
Yue Shi, MD
- Recruiting
The Cancer Hospital affiliated to Tianjin Medical University
Tianjin, Tianjin Municipality
Jin Zhang, MD
Jin Zhang, MD
- Recruiting
Hospital of Xinjiang Production and Construction Corps
Ürümqi
Shuanghu Yuan, MD
Shuanghu Yuan, MD
- Recruiting
Third Hospital of Xingtai
Xingtai
Jingjing Yu, MD
Jingjing Yu, MD
- Recruiting
Yingshan Maternal and Child Health Hospital
Yingshan
Yue Chen, MD
Yue Chen, MD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- ultrasound plus clinical breast examination
- Keywords
- breast cancer, screening, ultrasound, risk model
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound plus clinical breast examinationOther
all the participants will be required to fill risk factor questionaires and then be screened with ultrasound plus physical examination every year
| Study group | Role | What they receive |
|---|---|---|
| group 1 | ultrasound plus clinical breast examination Receives: Other: ultrasound plus clinical breast examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cancer detected in the high-risk group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang SUN, Peking Union Medical College Hospital
- Investigators
- Sun Qiang, MD, Study chair, PUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268643
- Sponsor's protocol ID
- PUMCH-breast-screening 2
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-based Breast Cancer Screening in Chinese Women
- ClinicalTrials.gov ID
- NCT02268643
- Acronym / sponsor ID
- PUMCH-breast-screening 2
- Conditions
- Breast Cancer
- Keywords
- breast cancer, screening, ultrasound, risk model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: ultrasound plus clinical breast examinationultrasound plus clinical breast examination |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy women without breast-related symptoms
Key inclusion criteria (2 listed)
- Written informed consent；
- residence from community or working units
Key exclusion criteria (7 listed)
- pregnancy；
- lactation；
- known metastatic cancer；
- signs or symptoms of breast disease；
- presence of breast implants, breast surgery within prior 12 months；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound plus clinical breast examinationall the participants will be required to fill risk factor questionaires and then be screened with ultrasound plus physical examination every year | Other | group 1 |
Primary outcome
number of cancer detected in the high-risk group
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Qiang, MD study chair
PUMCH
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Peking Union Medical College Hospital at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Qiang, MD (86-010-69152701, sunqiangpumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cancer detected in the high-risk group (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.