Evaluation of Circulating DNA as a Biomarker of Residual Disease After Chemoradiotherapy for Locally Advanced Head and Necksquamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- cDNA detection and objective response 3 months after the end of chemoradiotherapy
研究概览
简要总结
The goal of this ancillary clinical trial is to evaluated circulating DNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carninoma.
The main question it aims to answer is :
- Does circulating DNA (cDNA) be able to detect residual disease 3 months after the end of chemoradiotherapy ? Researchers will compare detection of cDNA at 3-months and objective response (clinical and radiological).
Participants will :
- be included in the main study (Neck-TAR)
- have a blood sample 1 and 3-month after the end of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Selection Criteria:
- •Patient included in NeckTAR study
- •Written informed consent signed for NeckTAR-IN study
- •Affiliation to the French social security system
排除标准
- 未提供
研究组 & 干预措施
cDNA detection
干预措施: blood sampling (Biological)
结局指标
主要结局
cDNA detection and objective response 3 months after the end of chemoradiotherapy
时间窗: 3 months after chemoradiotherapy
The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)
次要结局
- cDNA detection and objective response one month after the end of chemoradiotherapy(1 month after the end of chemoradiotherapy)
- Overall survival(At the end of the main study (27 months after the end of treatment))
- Progression-free survival(At the end of the main study (27 months after the end of treatment))
- cDNA kinetic(1- and 3-month after the end of chemoradiotherapy)
- Concordance of mutational profiles and HPV-HR genotypes between primary tumor, ctDNA at diagnosis and ctDNA(1- and 3-months after the end of chemoradiotherapy)
- Determining the most frequent mutations.(3-months after the end of chemoradiotherapy)