NCT05649475招募中不适用
Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年8月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Miller-Payne grading system
研究概览
简要总结
In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years-old at the time of consent to participate this trial
- •Patients with stage I-III invasive breast cancer
- •No prior anti-cancer treatment
- •Felt to be a possible candidate for neoadjuvant therapy by their physician
排除标准
- •Known to have other aggressive malignant tumor in the past 5 years.
- •Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.
- •There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
- •The investigator determines that subjects are not appropriate to participate in the study due to other factors.
结局指标
主要结局
Miller-Payne grading system
时间窗: 3 years
Residual cancer burden (RCB)
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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