The goal of this clinical trial is to learn if robotic ultrasound screening works as well as or better than traditional sonographer-led screening for detecting breast cancer. It will also explore how well participants follow recommended post-screening care. The main questions it aims to answer are: Does robotic ultrasound screening detect more cases of breast cancer compared to traditional sonographer-led screening? How well do participants follow up on recommended care after robotic ultrasound screening? Researchers will compare robotic ultrasound screening to traditional sonographer-led screening to see if robotic ultrasound works effectively for breast cancer screening. Participants will: Receive a breast ultrasound performed either by a robotic system or a human sonographer. Undergo follow-up management based on their BI-RADS classification.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
70,000
The ultrasound robot automatically scans the breasts of subjects via its mechanical arm and generates images.The diagnosis is made based on the radiologist's interpretation of the images.
Rural health centers and community health centers
Xiantao, Hubei, China
RECRUITINGThe detection rate of breast cancer
Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Cancer type
Non-invasive cancer (DCIS), early invasive cancer, and invasive cancer.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
The early diagnosis rate
The early diagnosis rate is defined as the number of breast cancer cases with TNM stage 0, I, or IIa divided by the number of women diagnosed with breast cancer or other malignant breast tumors during screening\*100.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Lymph node status
Presence of lymph node metastasis; size, morphology, internal structure, margin characteristics, and vascularity of metastatic lymph nodes.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer clinical stage
TNM staging, representing tumor size (T), lymph node involvement (N), and distant metastasis (M).
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Histological Grading of Breast Cancer
The internationally accepted Nottingham Histological Grading System is used. This system provides a semi-quantitative and objective assessment of invasive breast cancer. It evaluates three parameters: the proportion of tubule formation, nuclear pleomorphism, and mitotic count. The scores of the three parameters are added together. A total score of 3-5 indicates Grade 1 (G1, well-differentiated/low grade). A total score of 6-7 indicates Grade 2 (G2, moderately differentiated/intermediate grade). A total score of 8-9 indicates Grade 3 (G3, poorly differentiated/high grade).
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer screen recall rate
Breast cancer screen recall is defined as further assessment triggered by abnormal ultrasound findings (BI-RADS 0 or 3 and above). The recall rate is the number of women actually recalled divided by the number of women screened.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
The positive predictive value
The positive predictive value of recall is the percentage of recalled women who are diagnosed with breast cancer.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
The breast cancer biopsy rate
The breast cancer biopsy rate is defined as the number of women who actually underwent biopsy divided by the number of women screened. The positive predictive value of biopsy is defined as the percentage of women diagnosed with breast cancer among those who received a biopsy.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Referral adherence rate
Defined as the average adherence to recommended referral for confirmed diagnosis (biopsy and histopathology). It is calculated as the number of women actually referred divided by the number of women recommended for referral.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Interval cancer incidence
Defined as the proportion of women who had a negative or false-positive screening (i.e., no ductal carcinoma in situ or invasive breast cancer) and were subsequently diagnosed with invasive breast cancer within a certain period after screening. Following the national breast cancer screening guideline recommending screening every 2-3 years, this study will evaluate the interval cancer incidence at 24 months, i.e., the proportion of women diagnosed with breast cancer 24 months after a negative screen or 6-24 months after a false-positive screen.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer mortality
Defined as the number of deaths due to breast cancer within 24 months after screening divided by the total number of women screened.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
All-cause mortality
Defined as the total number of deaths from any cause within 24 months after screening divided by the total number of women screened.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Post-screening management adherence
Defined as the proportion of women who completed the recommended follow-up medical actions after screening (referral, re-examination, additional tests, etc.). The adherence rate is calculated as the number of participants who completed the recommended management within the specified time / the number of participants requiring further management \* 100%.
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
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