Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma
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
- •Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
- •No evidence of distant metastasis (M0)
- •Receive standard radical treatment
- •Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained
排除标准
- •WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Treatment with palliative intent
- •Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- •Severe intercurrent disease
结局指标
主要结局
Progression-free survival
时间窗: 3 years
Progression-free survival is calculated from the date of diagnosis of NPC to the date of progression of NPC or the date of death from any cause, whichever comes earlier.
次要结局
- overall survival(3 years)
- EBV DNA clearance rate(during the first month)
- locoregional failure-free survival(3 years)
- Distant metastasis-free survival(3 years)
研究者
Ying Sun
Vice-president
Sun Yat-sen University