NCT06606028招募中不适用
Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Cumulative incidence rate of ctDNA
研究概览
简要总结
This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.
详细描述
PRIMARY OBJECTIVE:
I. To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC.
SECONDARY OBJECTIVES:
- To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC.
- To describe the association of quantitative ctDNA levels with time-to-event outcomes (overall survival (OS), disease-free survival (DFS), and time to recurrence (TTR)).
- To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume.
OUTLINE:
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
- •Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.
- •Participants must be age >=18 years.
- •Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
- •Participants must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).
结局指标
主要结局
Cumulative incidence rate of ctDNA
时间窗: Up to 2 years
Cumulative incidence will be estimated by evaluating the cumulative incidence of positive ctDNA (non-zero) with death as a competing risk.
次要结局
- Proportion of participants at diagnosis with a positive (non-zero) ctDNA result.(Up to 2 years)
- Association of association of quantitative ctDNA levels with overall survival (OS)(Up to 2 years)
- Association of association of quantitative ctDNA levels with disease-free survival (DFS)(Up to 2 years)
- Association of association of quantitative ctDNA levels with time to recurrence (TTR)(Up to 2 years)
- Association of quantitative ctDNA levels with follow-up imaging tumor volume.(Up to 2 years)
研究者
研究点 (1)
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