Study on the Biological Prediction Models of Radiation Pneumonitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- radiation pneumonitis grade >=2 or 3
研究概览
简要总结
Radiation pneumonitis is the most common complication and the major dose-limiting toxicity associated with radiotherapy, which can cause poor quality of life or life-threatening symptoms and might hinder the tumor-controlling effects of radiotherapy. Consequently, establishing reliable predictors for the occurrence of RP is of great significance such that the therapeutic effects of RT can be maximized while minimizing its adverse effects. The aim of this study is to figure out the biological prediction models of radiation pneumonitis.
详细描述
- Establish a clinical data base for the lung cancer patients treated with radiotherapy in Tongji Hospital.
Data including age, gender, smoking state, KPS, pulmonary function, disease history, histology, stage, surgery, chemotherapy, dosimetric parameters of radiotherapy were collected.
Peripheral blood was collected from all patients enrolled. All patients enrolled in this study are examined during and one month after radiotherapy. Then, the patients are followed every three months for the first year and every six months thereafter. At each follow-up visits, all patients are asked to undergo a chest X-ray or CT and clinical information, including symptoms, is collected. RP is graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0. 2. Select candidate genes and pathways which may be associated with radiation pneumonitis and identify their tagSNPs by Haploview. 3. Use Kaplan-Meier and Cox model to analyze the association of all the factors collected with radiation pneumonitis. 4. Establish a biological prediction models for radiation pneumonitis based on the statistics analysis
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
- •Clinical diagnosis of lung cancer by histology
- •Radiation dose at least 45 Gy
- •Life expectancy of at least 6 months
- •Voluntarily signed the informed consent
排除标准
- •Previous thoracic irradiation
- •Severe cardiopulmonary diseases
结局指标
主要结局
radiation pneumonitis grade >=2 or 3
时间窗: 12 months after radiotherapy
次要结局
未报告次要终点
研究者
Xianglin Yuan
Professor, Chief Physician
Huazhong University of Science and Technology
