Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,981
- 试验地点
- 4
- 主要终点
- two breast ultrasound identified benign lesion
研究概览
简要总结
This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •with single breast lesion(maximum diameter>0.8 cm)
- •agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound
- •sign the informed consent
排除标准
- •lost to follow-up
- •failed to take the second breast ultrasound six month after the first breast ultrasound
结局指标
主要结局
two breast ultrasound identified benign lesion
时间窗: between first detection of breast lesion and the second ultrasound(six month)
for patients regarded as benign by the breast ultrasound, they will receive a second breast ultrasound after six month(this is regular examination for patients with first detected breast lesion). If the second ultrasound indicates benign, the lesion will be regarded as benign
breast biopsy proved malignant or benign lesion
时间窗: between breast ultrasound and biopsy(one week)
for patients regarded as malignant by the breast ultrasound, breast biopsy results are used as reference test, which determines the breast lesion is malignant or benign
次要结局
未报告次要终点
研究者
Tao OUYANG
Chairman of Breast Center of Beijing Cancer Hospital
Peking University