Remote Breast Cancer Screening Study

The First Affiliated Hospital of the Fourth Military Medical University

Status: Active, not recruiting

Conditions: Breast Cancer; Ultrasound Imaging; Cancer Screening; AI (Artificial Intelligence); Mass Screening

Treatments: Diagnostic Test: Second-reading; Diagnostic Test: Tow views-reading; Diagnostic Test: Handheld US-screening; Diagnostic Test: Concurrent-reading; Diagnostic Test: Conventional-reading

Study type: Observational

Funder types: Other

Identifiers

NCT04527510

2021LC2210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,333 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Any age at 35 and over
2. Screening breast cancer with AB US
3. Obtaining written informed consent

Exclusion criteria

1. symptoms of breast cancer
2. surgical of breast within 12 months prior to the study
3. known diagnosis breast cancer
4. poor image quality
5. follow-up was less than 12 months

Trial design

6,333 participants in 5 patient groups

Conventional-reading

Treatment:

Diagnostic Test: Conventional-reading

Second-reading

Treatment:

Diagnostic Test: Second-reading

Concurrent-reading

Treatment:

Diagnostic Test: Concurrent-reading

Tow-view-reading

Treatment:

Diagnostic Test: Tow views-reading

Handheld US-screening

Treatment:

Diagnostic Test: Handheld US-screening