Recurrence Monitoring in NSCLC Using Circulating Tumor DNA
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This research study is investigating the role of cell free tumor DNA profiling in determining disease relapse and/or progression for patients with advanced NSCLC.
详细描述
The objective of this study is to determine the ability of cell free tumor DNA genomic profiling to predict disease relapse or progression while on therapy for advanced stage NSCLC in comparison to current standard objective measures of disease relapse or progression.
This study is a prospective observational study. The investigators will assess whole genome sequencing from patient blood samples collected alongside routine blood draws with each treatment cycle to determine the tumor load score at each timepoint while on therapy. CT images will be obtained at routinely ordered timepoints throughout therapy and will be used in the assessment for standard clinical or radiographic evidence of disease progression. These methods of measuring disease progression will be compared in a lead time analysis.
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
- •Treatment naïve biopsy confirmed not surgically resectable stage III or greater NSCLC
- •Baseline CT imaging available
排除标准
- •Patients unable to undergo biopsy for initial tissue diagnosis
- •Patients who do not wish to pursue standard of care therapy
- •Patients with another diagnosis of malignancy
结局指标
主要结局
Progression Free Survival
时间窗: 24 months
Clinical or radiographic based PFS
次要结局
未报告次要终点
研究者
Aditya Sarvaria, MD
Investigator
Scripps Translational Science Institute