Monitoring Radiation Induced Cardiac Damage by Blood Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in percentage of rise of the level of NT pro BNP after radiotherapy
研究概览
简要总结
Rationale:
Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.
Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.
Objective:
The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.
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
- •Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)
- •Older than 18 years
- •Written informed consent
排除标准
- •Prior radiotherapy to the chest including radiotherapy for breast cancer
- •Patients treated with palliative intent
结局指标
主要结局
Change in percentage of rise of the level of NT pro BNP after radiotherapy
时间窗: At 1 year after end of radiation therapy
次要结局
- Change in percentage of rise of hs-TNT during or after treatment(At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy.)
- Cardiac events(After start treatment up to 2 years after end of radiation therapy.)