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临床试验/NCT04417985
NCT04417985已完成不适用

Integrating Biomarkers From Serum/Plasma and Molecular Images to Predict Occult Distant Metastases in Nasopharyngeal Carcinoma Patients With M0 Disease

Chang Gung Memorial Hospital0 个研究点目标入组 112 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
主要终点
Recurrence-free survival

研究概览

简要总结

Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its epidemiology, pathology, and treatment outcome. Although NPC is a radiosensitive tumor, distant recurrence remains a clinical challenge. Therefore, the investigators conducted this study to prospectively investigate the role of imaging and blood biomarkers in predicting the prognosis of NPC patients.

详细描述

  1. Background:

Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its epidemiology, pathology, and treatment outcome. NPC has a good local tumor control rate but a higher incidence of distant metastasis compared with squamous cell carcinomas of other regions of the head and neck. Thus, it's usually considered a distinct study group.

A good prognostic model for the development of distant failure for NPC patients is still lacking. It is well known that Epstein-Barr virus (EBV) genomes are present in almost every NPC tumor cell, irrespective of histologic differentiation and geographic distribution. Various EBV-derived/related factors, therefore, have been used as NPC tumor markers, including EBV-specific viral capsid antigen (VCA) IgA and cell-free EBV DNA. The measurement of cell-free EBV DNA load has already been shown to be a good pretreatment prognostic indicator. Another important feature of NPC is that the tumors are characterized by heavy infiltration of nonmalignant lymphocytes and might play an important role in tumorigenesis; and cytokines and chemokines may represent the key mediators of this interaction. Compelling evidence has also emerged in recent years suggesting that cytokines and chemokines play important roles in regulating processes critical to tumor progression, such as proliferation and metastasis.

Beyond blood biomarkers, standard uptake value (SUV) from FDG PET could predict treatment failure in NPC patients. On the other hand, apparent diffusion coefficient (ADC) from diffusion-weighted MRI (DWI) has been shown to be an important prognostic marker in cancer patients, including head and neck cancer. 2. Aim:

To investigate the roles of imaging and blood biomarkers in predicting distant failures, recurrences, and survival in NPC patients. 3. Study design:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Biopsy proved primary M0 nasopharyngeal carcinoma

排除标准

  • Woman with pregnancy or during lactation
  • A history of other malignancies or presence of recurrent tumors
  • A serum glucose level > 200mg/dL before PET scan

结局指标

主要结局

Recurrence-free survival

时间窗: 5 years

The time between the end of chemoradiotherapy and the date of recurrence or censored at the date of the last follow-up

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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