Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- major pathological response
研究概览
简要总结
This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma.
详细描述
Primary endpoint: Evaluation of the major pathological response of nasopharyngeal carcinoma patients.
Secondary endpoint: Evaluation of failure-free survival and overall survival of nasopharyngeal carcinoma patients.
Outline: This is a prospective observational study. Patients of nasopharyngeal carcinoma undergo inductive chemotherapy and concurrent chemoradiotherapy. Whole blood is obtained from patients when recruited, completing 10, 20, 32 fractions of radiation therapy, 3 months after radiation therapy and disease progression. Tumor tissue specimens are obtained from patients when recruited and disease progression. The samples are analyzed for biomarkers and spatial transcriptomics. The biomarkers and spatial transcriptomics are correlated with clinical outcomes (major pathological response, progression-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).
The analysis aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help in precision medicine of 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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed nasopharyngeal carcinoma
- •No evidence of distant metastasis (M0)
- •Written informed consent
排除标准
- •Treatment with palliative intent
结局指标
主要结局
major pathological response
时间窗: 3 months after radiation therapy
次要结局
- Overall Survival(2 years after radiation therapy)
- Progression-free Survival(2 years after radiation therapy)
研究者
Lirong Wu
Associate Professor
Jiangsu Cancer Institute & Hospital
