NCT05448703招募中不适用
A Multicenter Prospective Observational Study on Predictive Models and Clinical Outcome of Radiation Pneumonitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Radiation pneumonitis
研究概览
简要总结
Radiation pneumonitis is the main dose-limiting toxicity of thoracic radiotherapy, which can affect life quality, survival, and the tumor-controlling effects of patients receiving thoracic radiotherapy.
The purpose of this study is to:
- Identify biomarkers including serum proteins, gene expression, genetic changes, and epigenetic modifications that determine radiation pneumonitis.
- Investigate the relationship between radiation pneumonitis and other toxicities induced by radiotherapy.
- Construct a predictive model for radiation pneumonitis.
- Evaluate survival and treatment outcome of patients with radiation pneumonitis.
详细描述
- Collect clinical information, CT images, and peripheral blood of the lung cancer patients treated with thoracic radiotherapy in Tongji Hospital, Hubei Cancer Hospital, and Jingjiang People's Hospital.
- Follow up the enrolled patients. 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 CT, and information including survival status, symptoms, CT images, and treatment is collected. Radiation pneumonitis and other toxicities induced by radiotherapy are graded by two radiation oncologists according to the Common Terminology Criteria for Adverse Events 4.0 (CTCAE4.0).
- Detect serum proteins, gene expression profile, single-nucleotide polymorphisms, and epigenetic modifications that may be associated with radiation pneumonitis.
- Screen biomarkers that are associated with radiation pneumonitis via univariate and multivariate Cox regression analysis.
- Construct a predictive model of radiation pneumonitis based on clinical information, radiomics, and biomarkers via machine learning or Least absolute shrinkage and selection operator.
- Use Kaplan-Meier and Cox model to analyze the association of radiation pneumonitis with survival and efficacy of antitumor treatment.
- Identify biomarkers and predictors of other toxicities induced by radiotherapy including radiation esophagitis, cardiotoxicity and radiodermatitis.
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
- •Clinical diagnosis of lung cancer by histology
- •Radiation dose at least 45 Gy
- •Karnofsky >60
- •Life expectancy of at least 6 months
排除标准
- •Previous thoracic irradiation
- •Severe cardiopulmonary diseases
结局指标
主要结局
Radiation pneumonitis
时间窗: 12 months after radiotherapy
radiation pneumonitis grade \>=2 or 3 graded by CTCAE4.0. \[Time Frame: 12 months after radiotherapy\]
Overall Survival
时间窗: 5 years after radiotherapy
A long-term follow up will be scheduled to allow a complete survival analysis.
次要结局
- Other injuries induced by radiotherapy(5 years after radiotherapy)
研究者
Xianglin Yuan
Professor, Chief Physician
Huazhong University of Science and Technology
研究点 (3)
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