Breast CancerNCT01880853
Ultrasound and Mammography for Screening Breast Cancer in Chinese Women
A study testing mammography, ultrasound and mammography and ultrasound in people with Breast Cancer, run by Peking Union Medical College Hospital at 14 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- mammography, ultrasound and mammography and ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47,709 participants
- Where
- 14 sitesChina
- Study dates
- Nov 2008to Dec 2011
- Phase
- Interventional
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
14 sites in 1 country.
14 sites in 1 country
China14 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Beijing ChaoYang Hospital affiliated to the Capital Medical University
Beijing, Beijing Municipality
Beijing Hospital affiliated to Ministry of Health
Beijing, Beijing Municipality
Chinese 307 Hospital affiliated to the People's Liberation Army
Beijing, Beijing Municipality
First Hospital affiliated to Peking University
Beijing, Beijing Municipality
The Cancer Institute & Hospital, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
The General Hospital affiliated to Beijing Military Area Command
Beijing, Beijing Municipality
Southwest Hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality
Maternity & Child Care Center of Qinhangdao
Qinhuangdao, Hebei
The Cancer Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
ShanXi Traditional Medicine Hospital
Taiyuan, Shanxi
The Cancer Hospital affiliated to Tianjin Medical University
Tianjin, Tianjin Municipality
YingBin Surgery Hospital of Yancheng
Yancheng, Jiangsu
Population and Family Planning Service Center of Zhuhai
Zhuhai, Guangdong
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- mammography, ultrasound, mammography and ultrasound
- Keywords
- breast cancer, screening, mammography, ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mammographyOther
participants were screened by mammography alone every year
ultrasoundOther
participants were screened by ultrasound alone every year
mammography and ultrasoundOther
Participants were screened by both mammography and ultrasound every year
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | screening with mammography alone Receives: Other: mammography |
| group 2 | Experimental | screening with ultrasonography alone Receives: Other: ultrasound |
| group 3 | Experimental | screening with both mammography and ultrasound Receives: Other: mammography and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening yield
Sensitivities, specificities, positive predictive values, and negative predictive values
Measured: 3 years
Secondary outcomes (1)
Cost-effectiveness
cost of each screening modility to detect one cancer
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 posted19 Jun 2013 (estimated)
- Study startNov 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47,709 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun Qiang, MD, Study chair, PUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880853
- Sponsor's protocol ID
- PUMCH-breast-screening
- Status last verified
- Sep 2013
- First submitted
- 14 Jun 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shen S, Zhou Y, Xu Y, Zhang B, Duan X, Huang R, Li B, Shi Y, Shao Z, Liao H, Jiang J, Shen N, Zhang J, Yu C, Jiang H, Li S, Han S, Ma J, Sun Q. A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women. Br J Cancer. 2015 Mar 17;112(6):998-1004. doi: 10.1038/bjc.2015.33.
PubMed 25668012
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Mammography for Screening Breast Cancer in Chinese Women
- ClinicalTrials.gov ID
- NCT01880853
- Acronym / sponsor ID
- PUMCH-breast-screening
- Conditions
- Breast Cancer
- Keywords
- breast cancer, screening, mammography, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,709 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jun 2013 (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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: mammographyscreening with mammography alone |
| group 2 | Experimental | Other: ultrasoundscreening with ultrasonography alone |
| group 3 | Experimental | Other: mammography and ultrasoundscreening with both mammography and ultrasound |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| mammographyparticipants were screened by mammography alone every year | Other | group 1 |
| ultrasoundparticipants were screened by ultrasound alone every year | Other | group 2 |
| mammography and ultrasoundParticipants were screened by both mammography and ultrasound every year | Other | group 3 |
Primary outcome
screening yield
Time frame: 3 years
Sensitivities, specificities, positive predictive values, and negative predictive values
1 secondary outcome
Cost-effectiveness
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Derived from this study: PubMed 25668012Shen S, Zhou Y, Xu Y, Zhang B, Duan X, Huang R, Li B, Shi Y, Shao Z, Liao H, Jiang J, Shen N, Zhang J, Yu C, Jiang H, Li S, Han S, Ma J, Sun Q. A multi-centre randomised trial comparing ultrasound vs mammography for screening breast cancer in high-risk Chinese women. Br J Cancer. 2015 Mar 17;112(6):998-1004. doi: 10.1038/bjc.2015.33.
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mammography, ultrasound and mammography and ultrasound in people with Breast Cancer, run by Peking Union Medical College Hospital at 14 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: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
screening yield (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880853, which also lists 1 linked publication.
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 10 Sep 2013.