A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Different grades radiotherapy-induced oral mucositis
研究概览
简要总结
Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age.
- •Voluntarily sign informed consent.
- •The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor.
- •Need to be treated with radiotherapy.
- •ECOG PS Score: 0/1.
排除标准
- •There are contraindications to radiotherapy.
- •Combined with other tumors.
- •Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
- •At the investigator's discretion, those who was not considered to be suitable for participation in the study.
结局指标
主要结局
Different grades radiotherapy-induced oral mucositis
时间窗: Through study completion, up to 3 years
The incidence different grades of radiotherapy-induced oral mucositis will be calculated.
次要结局
- Start and duration of radiotherapy-induced oral mucositis(Through study completion, up to 3 years)
- Side effects of radiotherapy(Through study completion, up to 3 years)
- Tumor response(Through study completion, up to 3 years)