Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Percentage of patients with a detectable mutation in ctDNA
研究概览
简要总结
Locally advanced head and neck squamous cell carcinoma (LAHNSCC) is a heterogeneous disease, associated with a poor prognosis and no improvement in overall survival for years. Furthermore, treatments (surgery, radiotherapy, chemotherapy) are frequently associated with acute and late toxicities. Beside p16/HPV + tumors, only TNM classification can help estimating the prognosis of the patients. A better evaluation of the prognosis and of the risk of metastatic spread would help defining the best treatment.
Circulating tumor DNA (ctDNA) has been reported as both a prognostic factor and a non-invasive way to assess tumor relapse in several cancer types. Few data are available in HNSCC, and no data among p16/HPV- cancers. Indeed, ctDNA assessment is usually based on tumor mutation monitoring. But if recurrent mutations are frequent in several cancers types (PIK3CA, KRAS, ESR1, TERT…), there is no recurrent mutation observed in HNSCC. Thus ctDNA assessment in LAHNSCC must be performed after the identification of a tumor specific mutation for each patient.
In that context, the aim of this study is to perform a molecular analysis of primary LAHNSCC, and to look for the amount of ctDNA before surgery, after surgery, and during 18 months of follow up.
详细描述
The patients will be enrolled before surgery and follow-up during 18 months. During patient participation, 20 ml of blood will be collected 7 times (before and after surgery, 6 months after diagnosis and every 3 months thereafter until 18 months of follow up).
Mutation analysis on tumor and healthy tissue will be performed on primary tumors and lymph node dissection, after removal by the surgeon.
Circulating tumor DNA will be detected on blood sample
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Operable Head and neck squamous cell carcinoma (T3-T4 stage and/or N+)
- •No p16 expression
- •Curative treatment proposed based on surgery + radiotherapy (+/- chemotherapy)
- •Written consent signed
排除标准
- •Metastatic spread
- •Previous radiotherapy of head or neck
- •Previous HNSCC (except carcinoma restricted to glottis, with a surgery treatment alone and >3 years of follow up without relapse)
结局指标
主要结局
Percentage of patients with a detectable mutation in ctDNA
时间窗: 18 months
number of patient with detectable mutation with personalized molecular probe
次要结局
- Kinetics of ctDNA in case of relapse(18 months)
- Kinetics of ctDNA(18 months)
- progression free survival(18 months)