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临床试验/NCT03893461
NCT03893461Unknown不适用

Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年3月26日最近更新:
适应症

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

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

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

Stefan Starup Jeppesen

MD, PhD

Odense University Hospital

研究点 (1)

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