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