Diagnostic Biomarkers Exploration of Breast Cancer From Serum and Urine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The different biomarkers in malignant and benign breast diseases
研究概览
简要总结
The goal of this observational study is to find the diagnostic biomarkers in serum and urine from early breast cancer patients. The main questions it aims to answer are:
- compare the different biomarkers in serum and urine from breast cancer patients, benign lesions and healthy population.
- construct the best diagnostic model by machine learning to distinguish breast cancer and non-breast cancer patients.
Participants, including breast and non-breast cancer patients will be asked to provides blood and urine during their diagnosis and treatment process without changing the original treatment. When necessary, specimens will be collected during the surgery，without affecting pathological diagnosis.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signing the consent of informedness;
- •Patients with breast mass who need surgery after examination;
- •Cardiac ultrasound indicates that the blood score of the heart is within the normal range;
- •ECOG≤0-2 points;
- •Oversure function is acceptable.
排除标准
- •Merge other malignant tumors such as gynecologic oncology;
- •After evaluation, the internal organs are not suitable.
结局指标
主要结局
The different biomarkers in malignant and benign breast diseases
时间窗: It is expected to be one to two years.
By analyzing the differences (eg:PCA, FC and et al.)in the composition of proteins in blood and urine, biomarkers with significant differences between the two groups will be obtained.
Diagnostic models used different biomarkers by machine learning
时间窗: Within half a year after the completion of the test.
Using biomarkers that detect discrepancies, combined with machine learning to build early breast cancer diagnostic models.
次要结局
未报告次要终点