Application Research of B-ultrasound Assisted by Artificial Intelligence in Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,790
- 试验地点
- 3
- 主要终点
- Incidence rate of early breast cancer in each arm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS);
- •Personal history of any types of malignant neoplasms;
- •Known condition or suspicion of severe cardiopulmonary insufficiency, liver and kidney insufficiency and other systemic diseases;
- •Known condition or suspicion of serious comorbidities and average life expectancy less than 5 years;
- •History of lateral or bilateral mastectomy;
- •Disagree to participate in the study and follow-up interviews.
结局指标
主要结局
Incidence rate of early breast cancer in each arm
时间窗: 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.
次要结局
- Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods(4 years)
研究者
Ying Zheng
Director of Cancer Prevention Department, Fudan University Shanghai Cancer Center
Fudan University