Remote Breast Cancer Screening Based on Automated Breast Ultrasound Among Chinese Women: a Multi-center, Prospective, Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- The First Affiliated Hospital of the Fourth Military Medical University
- Enrollment
- 6333
- Locations
- 2
- Primary Endpoint
- The performance of breast cancer screening based on AB US with remote reading mode
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
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.
Investigators
Song Hongping
Principal Investigator
The First Affiliated Hospital of the Fourth Military Medical University
Eligibility Criteria
Inclusion Criteria
- •Any age at 35 and over
- •Screening breast cancer with AB US
- •Obtaining written informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode(4 years)
- Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode(4 years)
- Evaluate the performance of breast cancer screening according to the breast US device(4 years)