Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Changes in coagulation
研究概览
简要总结
The risk of thromboembolism is elevated in lung cancer patients. The present project investigates whether stereotactic body radiation therapy (SBRT) further increases the risk of thromboembolic disease in lung cancer patients.
If coagulation is activated by SBRT, this study could form the basis of new clinical trials investigating whether lung cancer patients may benefit from thromboprophylaxis during and after stereotactic body radiation therapy.
详细描述
In this study, the patients will have blood samples drawn three times (prior to start of stereotactic body radiation therapy, immediately after stereotactic body radiation therapy completion, four to six weeks after completing stereotactic body radiation therapy). The blood sample at the completion of stereotactic body radiation therapy is an extra compared to normal gathering of blood samples of patients with NSCLC treated with stereotactic body radiation therapy. Also extra glasses with blood will be gathered at each blood sample for storage in a biobank in order to be able to make future analysis on this material.
There is a minimal risk of developing infection or hematoma in connection with blood sampling but we consider this risk to be negligible. The total volume of 120 ml blood drawn over a period of 6 weeks is an inconsiderable risk for the patient.
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
- •Age > 18 years
- •Planned stereotactic body radiation therapy of lung cancer
排除标准
- •Inability to provide informed consent
- •Venous thrombosis within the last three months
- •Active cancer within the previous year except for lung cancer
结局指标
主要结局
Changes in coagulation
时间窗: From start of SBRT to end and 5 weeks after SBRT
endogenous thrombin
次要结局
未报告次要终点
研究者
Stefan Starup Jeppesen
MD, PhD
Odense University Hospital
