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临床试验/NCT02514109
NCT02514109终止不适用

Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

Centre Hospitalier Universitaire de Saint Etienne12 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
80
试验地点
12
主要终点
Likelihood ratio diagnostic criteria established on the study population

研究概览

简要总结

The diagnosis of sensory neuronopathy is difficult to establish because the only certainty criterion is based on the detection of specific lesions in the posterior spinal ganglion which is usually not possible. There is to date no clinical and electrophysiological criteria or validated biomarker for the diagnosis of this type of neuropathy. In a retrospective study, we analyzed the files of patients with peripheral sensory neuronopathy certain and established clinical and electrophysiological diagnostic criteria for sensitive neuronopathy. We therefore wish now validate these criteria and investigate possible associated antibodies on a prospective cohort of patients.

详细描述

All the patients (patient group and control) will be included in the study after giving their consent. The clinical, biological and electrophysiological data concerning the neuropathy will be collected. There is no specific follow-up for the study.

Blood samples will be retrospectively analyzed for antibody screening.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • A :Patients Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuronopathy.
  • B :Controls Male or female patient aged 18 years or more with a clinically pure sensory neuropathy, abnormal ENMG in sensory nerves in more than one limb and complete etiological assessment allowing a diagnosis of sensory neuropathy excluding a neuronopathy.

排除标准

  • Patient with a sensory-motor neuropathy or incomplete clinical evaluation

结局指标

主要结局

Likelihood ratio diagnostic criteria established on the study population

时间窗: baseline

The set of diagnostic criteria giving the best sensitivity and specificity for a diagnosis of sensory neuronopathy (composite measure)

次要结局

  • Identified antibodies(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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