Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.
试验速览
- 阶段
- 不适用
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- DFS at 2 years in HPV + and - tumors
研究概览
简要总结
High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS > 20% improvement). The principal objective is to determine the impact of the status of HR-HPV in the prognosis of the OP-SCC. The principal criteria is the 2-years DFS.
Secondary objective : virologic characteristics of HPV+ tumors.
详细描述
The study has no impact on the treatment of the observed population. The clinical study include TNM status, previous story of HPV infection, smoking and alcoholic habits, treatment and outcome during 5 years. The virologic study include : HPV type, E6-E7 viral charge of HPV16, viral DNA integration in the tumoral genome, HPV16 variants, expression of HPV 16, 18, 31, 45 coding oncoproteins E6-E7 mRNA. Moreover a serologic study will be done.
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
- •Squamous cell carcinoma of Oropharynx proven histologically
- •All stages TNM
- •informed consent
- •No previous or simultaneous Head Neck cancer
排除标准
- •Squamous cell carcinoma other than oropharynx
- •2nd synchronous SCC localization
- •No consent
- •age < 18
结局指标
主要结局
DFS at 2 years in HPV + and - tumors
时间窗: at 2 years
次要结局
- HPV status(At the inclusion)
- Overall survival(At 5 years)