Breast Cancer, Screening
Conditions
Keywords
Cancer epidemiology, Artificial intelligence, Ultrasound
Brief summary
AIBU is a randomized, open-label study assessing the effectiveness of an articificial intelligence-assisted breast ultrasound breast cancer screening strategy compared to standard screening (according to the current local guidelines in each participating area) in detecting late-stage breast cancers.
Detailed description
we enrolled asymptomatic women Women From January 2021 to December 2022, and then followed up for the next 1 year. The main study endpoint will be measured at the end of the one year after intervention.
Interventions
DEVICEAI-assisted breast ultrasound
AI-assisted breast ultrasound in community-based breast cancer screening
DEVICERoutine breast ultrasound
Routine breast ultrasound conducted by primary care physicians
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 35-70 who participated in breast cancer screening (Shanghai Rural Women Women two cancer screening project, national major public health service project Rural women breast cancer screening Project and Gynecological diseases and breast diseases screening project for retired and living difficult women) in Shanghai district
Exclusion criteria
* 1\. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS); 2. Personal history of any types of malignant neoplasms; 3. Known condition or suspicion of severe cardiopulmonary insufficiency, liver and kidney insufficiency and other systemic diseases; 4. Known condition or suspicion of serious comorbidities and average life expectancy less than 5 years; 5. History of lateral or bilateral mastectomy; 6. Disagree to participate in the study and follow-up interviews.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of early breast cancer in each arm | 4 years | Early cancers should meet any of the following criteria at the time of diagnosis: less than 20 milimeters in diameter, no metastatic lymph nodes in the axilla, no distant metastasis, non-invasive cancers, stage 0, stage I, and stage IIa IIb (T2N1M0) breast cancer according to American Joint Committee on Cancer (AJCC) 8th staging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods | 4 years | A true-positive screening result (sensitivity) was a positive result in a participant who was diagnosed with breast cancer by further diagnostic work-up. A false-positive screening result was a positive result in the absence of breast cancer. A true-negative screening result (specificity) was a negative result in the absence of breast cancer and a false-negative test result was a negative result followed by diagnosis of interval cancer. |
Countries
China
Outcome results
None listed