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临床试验/NCT04170205
NCT04170205Unknown不适用

Retrospective Study of Causes Associated With Small Fiber Neuropathies.

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
450
试验地点
1
主要终点
Prevalence of etiologies associated with SFN

研究概览

简要总结

Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis.

Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic.

As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population.

Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment.

The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN.

The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Age of majority (>18 years old)
  • Clinically managed patient at Brest University Hospital
  • Patient who had a skin biopsy with anatomopathological examination for SFN performed at the University Hospital of Brest

排除标准

  • Under age of majority (<18 years old)
  • Patient not followed at Brest University Hospital
  • Refusal to participate to the study

结局指标

主要结局

Prevalence of etiologies associated with SFN

时间窗: 1 year

Source population will be patients with symptoms that may be related to SFN, who have performed a biopsy for SFN. Patient will be considered to have SFN if he or she has a decrease in intra-epidermal distal density at nerve endings below the 5th percentile and at least one clinical sign in favour of small fibre neuropathy. Clinical signs in favour of SFN are as follows : Sensitive symptoms: burns, stings, numbness, tingling, hot/cold sensations, electric shocks, hyperesthesia, allodynia, intolerance of bed sheets, pruritus, restless legs. Vegetative symptoms: erectile disorders, dry syndrome, sweating, hot flashes, vertigo/discomfort (orthostatic hypotension), digestive and/or urinary disorders, resting tachycardia, palpitations Vascular symptoms: erythromelalgia, acrosyndrome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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