Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 517
- 试验地点
- 3
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.
详细描述
Primary Objective:
• To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas.
Secondary Objectives:
- To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations
- Levels of cfDNA and its association with both EFS and OS in patients receiving therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Male/female patients who are at least 18 years of age on the day of informed consent signing.
- •Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.
- •Provision of written informed consent for the study.
- •Pregnant women not included
- •Cognitively impaired adults are not included.
排除标准
- 未提供
研究组 & 干预措施
cell-free DNA (cfDNA) samples
cell-free DNA (cfDNA) samples from DLBCL participants before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.
Blood will be drawn 3 times (by vein)
干预措施: cell-free DNA (Diagnostic Test)
结局指标
主要结局
Overall Survival (OS)
时间窗: through study completion; an average 1 year
次要结局
未报告次要终点