Contribution of Residual Tumour DNA Testing on the Surgical Bed of Squamous Cell Carcinomas of the Oral Cavity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Residual tumro DNA on operating bed
研究概览
简要总结
The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.
详细描述
Squamous cell carcinomas of the oral cavity have a poor prognosis. The 5-year loco-regional recurrence rate is 45%. Surgery remains the standard treatment. The presence of invasive or insufficient surgical margins is an important histopronostic factor.
Current tools for intraoperative detection of insufficient margins have a very low sensitivity of around 10%. The aim here is to develop a more sensitive tool by looking for the presence of residual tumour DNA in the entire operating bed after squamous cell carcinoma excision
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
- •Signed informed consent
- •Patient with T1 to T4 squamous cell carcinoma of the oral cavity, regardless of lymph node status (all N) M0, operable
- •18 years of age or older
- •Member or beneficiary of a social security scheme.
排除标准
- •Absence of signed informed consent
- •Patient of protected age
- •Psychosocial problems
- •Not affiliated to or benefiting from a social security scheme
- •Previous cervical irradiation
- •Pregnant or breast-feeding women
- •Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
结局指标
主要结局
Residual tumro DNA on operating bed
时间窗: during the surgery
Proportion of patients with residual tumour DNA on the operating bed according to the presence or absence of adverse histological factors
次要结局
- Survival without locoregional recurrence rate(24 months)