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临床试验/NCT03981224
NCT03981224已完成不适用

Additional Blood Test Enhances Diagnostic Sensitivity of Relapse Detection and Predicts Survivals in High-risk Nasopharyngeal Carcinoma Patients With Post-radiation Detectable Plasma EBV DNA

Taichung Veterans General Hospital0 个研究点目标入组 706 人开始时间: 2012年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
706
主要终点
relapse-free survival (RFS)

研究概览

简要总结

An additional blood test at 2-3 months after RT is a valuable biomarker in predicting treatment outcome for NPC patients. Patients with persistently detectable EBV DNA during re-staging survey 2-3 months after RT should strengthen adjuvant therapy due to very high subsequent relapse rate and poor survivals.

详细描述

One week post-radiation therapy (RT) blood test showing persistently detectable EBV DNA is a very poor prognostic factor for nasopharyngeal carcinoma (NPC) patients. We hypothesize that additional EBV DNA confirmation test could enhance diagnostic sensitivity of relapse detection and predict survivals.

We screened 706 newly diagnosed NPC patients who finished curative RT with or without chemotherapy from March 2001 to December 2012. Additional EBV DNA blood test was performed at re-staging survey 2-3 months after RT. The association between treatment outcome (tumor relapse and patients' survival) and this additional blood test along with various clinical parameters were analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
  • NPC patients who finished curative RT with or without chemotherapy

排除标准

  • initial present M1 disease
  • Secondary primary cancer diagnosed within 5 years
  • performance status (WHO scale) less than 2

结局指标

主要结局

relapse-free survival (RFS)

时间窗: 5 years

From the end of treatment to clinical or pathological proven disease relapse

次要结局

  • Overall survival (OS)(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TCVGH

Jin-Ching Lin

Taichung Veterans General Hospital

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