Isolating and Testing Circulating Tumor DNA and Soluble Immune Markers During the Course of Treatment for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.
研究概览
简要总结
The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).
详细描述
Our plan is to collect blood from patients with advanced stage lung cancer who are scheduled to undergo systemic therapy. In this study we will utilize a novel technology for circulating tumor DNA detection in order to evaluate their presence in patients with lung cancer by comparing blood samples at six time points. We will obtain baseline blood and then collect blood at five time points during the course of the patient's chemotherapy treatments and at the end of treatment. These same blood collections will be used for the detection of soluble immune markers and evaluation of PBMCs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Advanced (non-resectable) malignancy in the thorax
- •Age >18 years old
- •Willing and able to provide consent
- •No prior history of neoadjuvant therapy
排除标准
- •Age <18 years old
- •Unable to provide consent
- •Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)
结局指标
主要结局
The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.
时间窗: 1 year
次要结局
未报告次要终点