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临床试验/NCT00956033
NCT00956033已完成不适用

Skin Biopsies in Chemotherapy-induced Neuropathy

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2008年11月最近更新:
适应症

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

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

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

Joost LM Jongen

J.L.M. Jongen, MD, PhD

Erasmus Medical Center

研究点 (1)

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