Skin Biopsies in Chemotherapy-induced Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- intraepidermal nerve fiber density/pain intensity
研究概览
简要总结
Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.
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
- •Patients with multiple myeloma receiving bortezomib
排除标准
- •Patients not able to provide informed consent
- •Patients with coagulation disturbances or immunocompromised patients
结局指标
主要结局
intraepidermal nerve fiber density/pain intensity
时间窗: one timepoint, i.e. date of skin biopsy
correlation between intraepidermal nerve fiber density and pain intensity
次要结局
未报告次要终点
研究者
Joost LM Jongen
J.L.M. Jongen, MD, PhD
Erasmus Medical Center
