NCT04214782尚未招募不适用
Detection of Ovarian Cancer Using an Artificial Intelligence Enabled Transvaginal Ultrasound Imaging Algorithm
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 主要终点
- diagnostic accuracy
研究概览
简要总结
Ovarian cancer is relatively rare but fatal with an annual incidence rate of 11.8 per 100 000 and a high mortality-to-incidence ratio of >0.6. The modest diagnostic accuracy of TVU has risen some concerns about the over-treatment.Now, with the development of artificial intelligence (AI), we may have a better chance to interpret TVU imagines with high efficiency, reproducibility and accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for Transvaginal Ultrasound examination for adnexal lesions;
- •Women aged over 18 years old;
- •Women willing to participant in this study evidenced by signing the informed consent.
排除标准
- •Women without adnexa for any reasons at the time of Transvaginal Ultrasound examination, including but not limited to receiving surgical removal for adnexa;
- •Women with a pathologic diagnosis of ovarian cancer before the Transvaginal Ultrasound examination;
- •Women with mental abnormal;
- •Women did not cooperate or participate in other clinical trials;
- •Pregnant or lactating women.
结局指标
主要结局
diagnostic accuracy
时间窗: 2 years
diagnostic accuracy comparison between Transvaginal Ultrasound diagnosis with and without Artificial Intelligence algorithm for ovarian cancer
次要结局
- time cost for Transvaginal Ultrasound image interpretation(2 years)
研究者
Qinglei Gao
Clinical Professor
Tongji Hospital
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