Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Plasma EBV during proton beam RT
研究概览
简要总结
How does plasma Epstein-Barr Virus (EBV) DNA level change during definitive radiation therapy for nasopharyngeal carcinoma (NPC) in the teenage and young adult cohort and does it correlate with outcomes?
详细描述
Children with NPC achieve superior survival outcomes compared to adults (10) and the prognostic value of plasma Epstein-Barr Virus (EBV) DNA has not been studied in children. Integration of MRI into early treatment response assessment will add further prognostic value and permits response-adapted therapy which can improve quality of survivorship children through toxicity reduction. It also allows identification of patients who either have had or are likely to have a suboptimal response to treatment, facilitating the potential consideration of treatment escalation.
The sample size of this study is not intended to change clinical practice, but rather provide a basis for international collaboration to achieve larger patient numbers.
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
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and young adults (8-30 years old)
- •Pathologically confirmed EBV-positive nasopharyngeal carcinoma
- •Stage I-IVA (AJCC 8th Edition)
- •Planned to commence curative-intent radiation therapy
排除标准
- •Recurrent NPC
- •Concurrent or previously treated EBV-associated malignancy
- •Prior radiation therapy
- •Contraindications to MRI
- •General anaesthetic requirement for MRI
结局指标
主要结局
Plasma EBV during proton beam RT
时间窗: 6 weeks
Taken weekly, prior to each session of chemotherapy. Change in plasma EBV DNA levels (EBV VCA-IgM Ab) from each blood sample time point.
次要结局
- EBV and tumour correlates(2 years)