Clinical trial NCT04527510: Remote Breast Cancer Screening Study
Official title: Remote Breast Cancer Screening Based on Automated Breast Ultrasound Among Chinese Women: a Multi-center, Prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Mass Screening
Cancer Screening
Ultrasound Imaging
AI (Artificial Intelligence)
Keywords: Remote breast cancer screening
AB US
AI
Scanning and reading patterns
Lead sponsor: The First Affiliated Hospital of the Fourth Military Medical University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 6333
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5714 women are needed (at least 12 cancer cases are expected with 80% power and 20% dropout)

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.

Eligibility criteria: 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

Primary outcomes:
measure: The performance of breast cancer screening based on AB US with remote reading mode
timeFrame: 4 years
Secondary outcomes:
measure: Evaluate the performance of AI on breast cancer screening based on AB US with remote reading mode
timeFrame: 4 years
measure: Evaluate the performance of the image acquisition and interpretation modes in breast cancer screening based on AB US with remote reading mode
timeFrame: 4 years
measure: Evaluate the performance of breast cancer screening according to the breast US device
timeFrame: 4 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of the Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing hospital of The fourth military medical university
name: Hongping Song, PHD,MD
role: PRINCIPAL_INVESTIGATOR
References: