A Clinical Study to Establish a Dynamic Prediction Model for Bone Metastases Based on Breast Cancer Real-world Data
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients
研究概览
简要总结
The purpose of this study is to identify the risk factors of bone metastasis in breast cancer patients so as to develop a dynamic prediction model using real world clinical data. The multicenter data will be retrospectively collected, and the clinical characteristics related to bone metastasis will be analyzed.
详细描述
Breast cancer is the most common malignant tumor in women worldwide and bones are the most common sites of metastases in breast cancer patients(~70%). Bone metastasis often leads to skeletal-related events (SREs) ,which may not only reduce the quality of life in patients, but also affect the long-term survival. Therefore, early detection and early intervention of bone metastasis are particularly important for breast cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with breast cancer by histopathology;
- •Age between 20 and 70 years old;
- •The first diagnosis time is between 2010 and 2020;
- •Complete diagnosis and treatment information, including basic information, breast cancer diagnosis, surgery, recurrence diagnosis data (including the diagnosis of the metastasis sites), anti-tumor treatment data, bone health and bone metastasis-related diagnosis and treatment data, etc.;
- •Sufficient available follow-up information.
排除标准
- •Missing important basic information (including initial and recurrent pathology, stage, pathological grade and time, surgery time, and drug treatment);
- •With distant metastasis at the initial diagnosis;
- •Patients with autoimmune diseases or aggressive viral infections (such as HIV or hepatitis);
- •Other malignant tumors;
- •Unclear information about distant metastasis.
结局指标
主要结局
To identify the risk factors and develop a prediction model for bone metastasis in breast cancer patients
时间窗: 60 months
The correlation between clinical characteristics and bone metastasis, and the accuracy of prediction model
次要结局
未报告次要终点
研究者
Ma Fei，MD
Chief physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences