Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 30
- 主要终点
- Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers
研究概览
简要总结
Head and neck cancers represent more than 500,000 cases per year worldwide, and often involve post-treatment relapse. The oral cavity is the most frequent site, but early disease stages are still insufficiently characterised and poorly detected. The study's aim is to better understand the oral mucosa somatic evolution, and how it can give rise to oral squamous cell carcinoma (OSCC).
This is a multi-centric, descriptive, non-interventional cohort in healthy adult subjects. The aim of the study is to detect the presence of OSCC driver gene mutations in healthy subjects' oral mucosa, quantify whether they provide cells with a selective advantage, and study the impact of tobacco and alcohol consumption on the mutational load. This study will not allow to identify potential malignant cells, and will be usable for diagnostic purposes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman aged 18 or more.
- •Subject coming to odontology practice for routine visit.
- •Subject having accepted to participate to the research by oral non-opposition
- •Subject having given additional written consent for genetic studies.
- •Smoking group criterion: subjects having smoked 100+ cigarettes/joints during their life.
排除标准
- •Personal history of cancer, whichever the type.
- •Treatment with anticoagulants or platelet aggregation inhibitors.
- •Bilateral lesions of the inner cheek preventing painless biological sample collection.
- •Subject under under guardians or curators
- •Pregnancy or breastfeeding
- •Cannabis usage
研究组 & 干预措施
Smokers
Healthy subjects having smoked 100 cigarettes or more during their life.
干预措施: Oral cytobrush (Other)
Non-smokers
Healthy subjects having smoked less than 100 cigarettes during their life.
干预措施: Oral cytobrush (Other)
结局指标
主要结局
Prevalence of non-synonymous OSCC driver mutations in the healthy mucosa of smokers
时间窗: 12 months
Difference in mean number of non-synonymous mutations found in OSCC driver genes between smokers and non-smokers.
次要结局
未报告次要终点