An Explorative Study on the Association of High Sensitivity C-Reactive Protein (hsCRP) and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- hsCRP levels
研究概览
简要总结
The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors
- •According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy
- •Willingness to sign the informed consent and return to enrolling institution for follow-up and data collection
排除标准
- •Patients do not conform to the inclusion criteria
- •Pregnant or Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •Vital organs dysfunction(for example, kidneys, heart, liver, lungs, brain)
- •Other contraindications or unsuitable conditions for radiotherapy
结局指标
主要结局
hsCRP levels
时间窗: Through treatments completion，12 weeks
The hscrp levels in the plasma samples from each participant were measured at the following time points: 1. at the time of diagnosis completion/before the initiation of the first neoadjuvant chemotherapy 2. before the initiation of each neoadjuvant chemotherapy 3. before the initiation of the first radiotherapy 4. during radiotherapy, once a week 5. 1 week and 4weeks after the last radiotherapy
Incidence of adverse events
时间窗: Through treatments completion，12 weeks
All adverse events were recorded during treatment(for example, oral mucositis, dermatitis).
次要结局
未报告次要终点
研究者
Jiarong Chen, MD
Principal Investigator
Jiangmen Central Hospital