Breast CancerNCT04527510
Remote Breast Cancer Screening Study
An observational study of Breast Cancer and Mass Screening, run by The First Affiliated Hospital of the Fourth Military Medical University at 2 sites in China.
Trial summary
A multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on Automated Breast Ultrasound (AB US) with remote reading mode. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Cancer, Mass Screening, Cancer Screening
- What is being tested?
- Conventional-reading, Second-reading and Concurrent-reading
- How many people
- 6,333 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2021to Aug 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 5714 women are needed (at least 12 cancer cases are expected with 80% power and 20% dropout)
Who may be able to join
- Any age at 35 and over
- Screening breast cancer with AB US
- Obtaining written informed consent
Who cannot join
- symptoms of breast cancer
- surgical of breast within 12 months prior to the study
- known diagnosis breast cancer
- poor image quality
- follow-up was less than 12 months
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, 710000
The First Affiliated Hospital of the Fourth Military Medical University
Xi'an, Shaanxi
About this study
Official title: Remote Breast Cancer Screening Based on Automated Breast Ultrasound Among Chinese Women: a Multi-center, Prospective, Cohort Study
A multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on Automated Breast Ultrasound (AB US) with remote reading mode.
Read the detailed description
The burden of breast cancer incidence and mortality is rapidly growing during the past two decades in China. Screening has been proven to be effective in detecting early-stage disease and reducing mortality of 10% to 39% due to breast cancer. US is used as a primary screening method among Chinese women because Asian women characteristically have higher-density breasts than other ethnic groups. However, US is dependent on operator experience, lack of standardized scanning protocols, limited ultrasound physician and heavy workloads. In order to improve the efficiency and quality of breast cancer screening among Chinese women, a new remote screening pattern based on AB US was proposed and studied for breast cancer in China. This multi-center, prospective, cohort study aims to evaluate the efficiency of breast cancer screening based on AB US with remote reading mode. In addition, we will also explore the practice value of AI on AB US screening and efficient image acquiring and reading modes of AB US.
- Conditions
- Breast Cancer, Mass Screening, Cancer Screening, Ultrasound Imaging, AI (Artificial Intelligence)
- Being tested
- Conventional-reading, Second-reading, Concurrent-reading, Tow views-reading, Handheld US-screening
- Keywords
- Remote breast cancer screening, AB US, AI, Scanning and reading patterns
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional-readingDiagnostic test
Two radiologists interpret at least three views of each breast without AI independently.
Second-readingDiagnostic test
One radiologist reads AB US images without AI first, then combines the indications of AI marks to make the final decision.
Concurrent-readingDiagnostic test
One radiologist identifies CAD marks first, then quickly browses the entire AB US examination to make the final decision.
Tow views-readingDiagnostic test
Two radiologists interpret only two views of each breast without AI independently.
Handheld US-screeningDiagnostic test
One radiologist screens the breast cancer using Handheld US and interprets images immediately.
| Study group | Role | What they receive |
|---|---|---|
| Conventional-reading | Not described Receives: Diagnostic Test: Conventional-reading | |
| Second-reading | Not described Receives: Diagnostic Test: Second-reading | |
| Concurrent-reading | Not described Receives: Diagnostic Test: Concurrent-reading | |
| Tow-view-reading | Not described Receives: Diagnostic Test: Tow views-reading | |
| Handheld US-screening | Not described Receives: Diagnostic Test: Handheld US-screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of breast cancer screening based on AB US with remote reading mode
The performance of breast cancer screening based on AB US with remote reading mode will be evaluated by cancer detection rate, recall rate, sensitivity, specificity, positive predictive value, early detection of breast cancer, interval cancers and time for image acquisition and interpretation.
Measured: 4 years
Secondary outcomes (3)
Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode
Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode (Conventional-reading vs. Second-reading / Concurrent-reading)
Measured: 4 years
Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode
Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode (two views vs. three views)
Measured: 4 years
Evaluate the performance of breast cancer screening according to the breast US device
Evaluate the performance of breast cancer screening according to the breast US device (Hand-held US vs. AB US)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2023
- Study completionAug 2025 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of the Fourth Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Hongping, The First Affiliated Hospital of the Fourth Military Medical University
- Investigators
- Hongping Song, PHD,MD, Principal investigator, Xijing hospital of The fourth military medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527510
- Sponsor's protocol ID
- 2021LC2210
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2020
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dang X, Gao Y, Ju Y, Yuan X, Lin H, Ren Y, Xiao Y, Shu R, Gu X, Moon WK, Song H. Automated Breast Ultrasound With Remote Reading for Primary Breast Cancer Screening: A Prospective Study Involving 46 Community Health Centers in China. AJR Am J Roentgenol. 2025 Jan;224(1):e2431830. doi: 10.2214/AJR.24.31830. Epub 2024 Oct 23.
PubMed 39440797
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Breast Cancer Screening Based on Automated Breast Ultrasound Among Chinese Women: a Multi-center, Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT04527510
- Acronym / sponsor ID
- 2021LC2210
- Conditions
- Breast Cancer, Mass Screening, Cancer Screening, Ultrasound Imaging, AI (Artificial Intelligence)
- Keywords
- Remote breast cancer screening, AB US, AI, Scanning and reading patterns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,333 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of the Fourth Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Aug 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.
A multi-center, prospective, cohort study to evaluate the efficiency of breast cancer screening based on Automated Breast Ultrasound (AB US) with remote reading mode.
Detailed description
The burden of breast cancer incidence and mortality is rapidly growing during the past two decades in China. Screening has been proven to be effective in detecting early-stage disease and reducing mortality of 10% to 39% due to breast cancer. US is used as a primary screening method among Chinese women because Asian women characteristically have higher-density breasts than other ethnic groups. However, US is dependent on operator experience, lack of standardized scanning protocols, limited ultrasound physician and heavy workloads. In order to improve the efficiency and quality of breast cancer screening among Chinese women, a new remote screening pattern based on AB US was proposed and studied for breast cancer in China. This multi-center, prospective, cohort study aims to evaluate the efficiency of breast cancer screening based on AB US with remote reading mode. In addition, we will also explore the practice value of AI on AB US screening and efficient image acquiring and reading modes of AB US.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Conventional-reading | – | Diagnostic Test: Conventional-reading |
| Second-reading | – | Diagnostic Test: Second-reading |
| Concurrent-reading | – | Diagnostic Test: Concurrent-reading |
| Tow-view-reading | – | Diagnostic Test: Tow views-reading |
| Handheld US-screening | – | Diagnostic Test: Handheld US-screening |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5714 women are needed (at least 12 cancer cases are expected with 80% power and 20% dropout)
Key inclusion criteria (3 listed)
- Any age at 35 and over
- Screening breast cancer with AB US
- Obtaining written informed consent
Key exclusion criteria (5 listed)
- symptoms of breast cancer
- surgical of breast within 12 months prior to the study
- known diagnosis breast cancer
- poor image quality
- follow-up was less than 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 |
|---|---|---|
| Conventional-readingTwo radiologists interpret at least three views of each breast without AI independently. | Diagnostic test | Conventional-reading |
| Second-readingOne radiologist reads AB US images without AI first, then combines the indications of AI marks to make the final decision. | Diagnostic test | Second-reading |
| Concurrent-readingOne radiologist identifies CAD marks first, then quickly browses the entire AB US examination to make the final decision. | Diagnostic test | Concurrent-reading |
| Tow views-readingTwo radiologists interpret only two views of each breast without AI independently. | Diagnostic test | Tow-view-reading |
| Handheld US-screeningOne radiologist screens the breast cancer using Handheld US and interprets images immediately. | Diagnostic test | Handheld US-screening |
Primary outcome
The performance of breast cancer screening based on AB US with remote reading mode
Time frame: 4 years
The performance of breast cancer screening based on AB US with remote reading mode will be evaluated by cancer detection rate, recall rate, sensitivity, specificity, positive predictive value, early detection of breast cancer, interval cancers and time for image acquisition and interpretation.
3 secondary outcomes
Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode
Time frame: 4 years
Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode
Time frame: 4 years
Evaluate the performance of breast cancer screening according to the breast US device
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 39440797Dang X, Gao Y, Ju Y, Yuan X, Lin H, Ren Y, Xiao Y, Shu R, Gu X, Moon WK, Song H. Automated Breast Ultrasound With Remote Reading for Primary Breast Cancer Screening: A Prospective Study Involving 46 Community Health Centers in China. AJR Am J Roentgenol. 2025 Jan;224(1):e2431830. doi: 10.2214/AJR.24.31830. Epub 2024 Oct 23.
- Individual participant dataSharing planned: Undecided
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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.
Hongping Song, PHD,MD principal investigator
Xijing hospital of The fourth military medical university
2 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 and Mass Screening, run by The First Affiliated Hospital of the Fourth Military Medical University at 2 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 3 inclusion and 5 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
The performance of breast cancer screening based on AB US with remote reading mode (time frame: 4 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 NCT04527510, 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 30 Apr 2024.