A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 267
- 试验地点
- 5
- 主要终点
- risk of recurrence
研究概览
简要总结
Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of OPSCC, thus representing attractive targets for the definition of novel molecular markers for this malignancy. Based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify OPSCC patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it
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
- •newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition,
- •managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy)
- •minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment.
- •neoplastic lesion contains ≥ 70% neoplastic cells
排除标准
- •with distant metastases at diagnosis,
- •who have been managed with palliative intent;
- •with previous history of head and neck cancer are not eligible
结局指标
主要结局
risk of recurrence
时间窗: 18 months
risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one
次要结局
未报告次要终点