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临床试验/NCT02490319
NCT02490319招募中不适用

Study on the Biological Prediction Models of Radiation Pneumonitis

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2008年9月最近更新:
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
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

  1. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xianglin Yuan

Professor, Chief Physician

Huazhong University of Science and Technology

研究点 (1)

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