Breast Cancer DiagnosisMUSDNCT04429269
A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
An observational study of Breast Cancer Diagnosis and Breast Cancer Screening, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Breast Cancer Diagnosis, Breast Cancer Screening
- What is being tested?
- mammography and ultrasound screening
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2020to 1 Jun 2023
- 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 70 years
- Women only
- Adult, Older adult
Study population: Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo ultrasound and X-rays
Who may be able to join
- Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray
Who cannot join
- Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100730
Songjie Shen, MD, 010 6915 8721, shensj@pumch.cn
About this study
Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.
Read the detailed description
Breast cancer has become the most common malignancy in women. Improving the early diagnosis of breast cancer can reduce mortality. Mammography is recommended as the main tool for screening and early diagnosis of breast cancer in the guidelines of European and American countries. However, the characteristics of dense breast and young onset of disease in Chinese women make the screening and early diagnosis strategies of Western countries, which are mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.
- Conditions
- Breast Cancer Diagnosis, Breast Cancer Screening
- Being tested
- mammography and ultrasound screening
- Keywords
- Mammography, ultrasound, breast cancer screening, early diagnosis
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mammography and ultrasound screeningDiagnostic test
Patients screened by both mammography and ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| mammography and ultrasound | mammography and ultrasound screening Receives: Diagnostic Test: mammography and ultrasound screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening yield
The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.
Measured: 3 years
Secondary outcomes (1)
cost-effectiveness
The cost-effectiveness of each screening modality to detect one case of breast 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 posted12 Jun 2020
- Study start12 Jun 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer DiagnosisStudies 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Songjie Shen, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429269
- Sponsor's protocol ID
- PUMCH-MUSD
- Acronym
- MUSD
- Status last verified
- Jul 2020
- First submitted
- 10 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual information of each participant of the trials is not shown in public, yet can be obtained upon reasonable requirements.
Publications
Wang Y, Li Y, Qu Y, Zhou Y, Sun Q, Shen S. Clinical and imaging characteristics of intraductal papillary neoplasms of the breast: a prospective trial. Discov Oncol. 2024 Dec 23;15(1):831. doi: 10.1007/s12672-024-01681-y.
PubMed 39715848Wang Y, Li Y, Song Y, Chen C, Wang Z, Li L, Liu M, Liu G, Xu Y, Zhou Y, Sun Q, Shen S. Comparison of ultrasound and mammography for early diagnosis of breast cancer among Chinese women with suspected breast lesions: A prospective trial. Thorac Cancer. 2022 Nov;13(22):3145-3151. doi: 10.1111/1759-7714.14666. Epub 2022 Sep 30.
PubMed 36177910
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
- ClinicalTrials.gov ID
- NCT04429269
- Acronym / sponsor ID
- MUSD / PUMCH-MUSD
- Conditions
- Breast Cancer Diagnosis, Breast Cancer Screening
- Keywords
- Mammography, ultrasound, breast cancer screening, early diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 12 Jun 2020 (actual)
- 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.
Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.
Detailed description
Breast cancer has become the most common malignancy in women. Improving the early diagnosis of breast cancer can reduce mortality. Mammography is recommended as the main tool for screening and early diagnosis of breast cancer in the guidelines of European and American countries. However, the characteristics of dense breast and young onset of disease in Chinese women make the screening and early diagnosis strategies of Western countries, which are mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mammography and ultrasound | – | Diagnostic Test: mammography and ultrasound screeningmammography and ultrasound screening |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo ultrasound and X-rays
Key inclusion criteria (1 listed)
- Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray
Key exclusion criteria (1 listed)
- Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients
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 |
|---|---|---|
| mammography and ultrasound screeningPatients screened by both mammography and ultrasound. | Diagnostic test | mammography and ultrasound |
Primary outcome
screening yield
Time frame: 3 years
The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.
1 secondary outcome
cost-effectiveness
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 9 Jul 2020.
- Derived from this study: PubMed 39715848Wang Y, Li Y, Qu Y, Zhou Y, Sun Q, Shen S. Clinical and imaging characteristics of intraductal papillary neoplasms of the breast: a prospective trial. Discov Oncol. 2024 Dec 23;15(1):831. doi: 10.1007/s12672-024-01681-y.
- Derived from this study: PubMed 36177910Wang Y, Li Y, Song Y, Chen C, Wang Z, Li L, Liu M, Liu G, Xu Y, Zhou Y, Sun Q, Shen S. Comparison of ultrasound and mammography for early diagnosis of breast cancer among Chinese women with suspected breast lesions: A prospective trial. Thorac Cancer. 2022 Nov;13(22):3145-3151. doi: 10.1111/1759-7714.14666. Epub 2022 Sep 30.
- Individual participant dataSharing planned: No. Individual information of each participant of the trials is not shown in public, yet can be obtained upon reasonable requirements.
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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.
Songjie Shen, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China
1 site 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 Diagnosis and Breast Cancer Screening, run by Peking Union Medical College Hospital at 1 site 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 1 inclusion and 1 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Songjie Shen, MD ((010) 6915 8721, shensj@pumch.cn), or a site near the patient. 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 NCT04429269, which also lists 2 linked publications.
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 9 Jul 2020.