Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on the EGFR in Skin Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors
研究概览
简要总结
RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin.
PURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.
详细描述
OBJECTIVES:
- Determine the effects of EGFR inhibitors on the EGFR pathway in the skin of cancer patients prior to and after receiving EGFR inhibitors (i.e., tyrosine kinase inhibitors and monoclonal antibodies).
- Compare the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin of these patients.
- Compare changes in the EGFR pathway with grade of rash in these patients.
- Compare changes in EGFR pathway effectors in the skin with serum TGFα levels in these patients.
OUTLINE: This is a pilot study.
Patients undergo skin punch biopsies and blood sample collection at baseline, within 1 week of developing skin rash, and 6 weeks after beginning treatment. Samples are analyzed by immunohistochemistry and western blot for phosphorylated MAP kinase, AKT, and EGF levels and TGFα levels. Patients also complete diagrams to indicate locations of the rash once weekly during the first 6 weeks of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors
时间窗: baseline and at 6 weeks
次要结局
- Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin(at 6 weeks)
- Comparison of changes in the EGFR pathway with grade of rash(at 6 weeks)
- Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot(at 6 weeks)
研究者
Laura W. Goff, MD
Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center