Mabtornib Protocol.Vascular, Metabolic and Hormonal Effects of Angiogenesis Inhibitors and Epidermal Growth Factor Receptor Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors.
研究概览
简要总结
Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify physiological processes. This study evaluates effects on vascular function, endocrine function and metabolism. Changes in these parameters will be analysed for predictive value for treatment efficacy.
详细描述
Background
In recent years, multiple new agents have been developed that inhibit angiogenesis and the epidermal growth factor receptor (EGFR) signalling pathway.
The cell signalling routes that are inhibited by these agents however are not only active in tumour formation but are also involved in physiological processes in normal tissue and organs. This means that these drugs do not only have an anti tumour effect but also modify several physiological processes that lead to side effects. Little is known about these side effects that generally are less severe than side effects of cytotoxic chemotherapy, but because targeted therapy is often administered for prolonged periods of time, these side effects can seriously affect quality of life.
Objectives
Primary objectives
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
- •Patients who will start with an angiogenesis inhibitor or EGFR inhibitor
- •Concomittant chemotherapy, immunotherapy or radiotherapy is allowed
- •Age above 18 years at start of treatment
- •Willingness to give written informed consent
排除标准
- •Unable to give written informed consent
- •Age under 18 years
结局指标
主要结局
Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors.
时间窗: after 3 and after 6 weeks of treatment
Vascular function tests at baseline, after 3 and after 6 weeks of treatment, blood and urine measurements as long as treatment is continued.
次要结局
- DNA analysis(day -7 till day -1)