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NCT04170205: EtioNPF

Causes Associated With Small Fiber Neuropathy (SFN).

Status unknown Last updated 20 November 2019
What this trial tests

trial in Small Fiber Neuropathy in 450 participants. Status unknown.

Timeline
15 November 2019
Primary endpoint
30 April 2020
30 April 2020

Quick facts

Lead sponsorUniversity Hospital, Brest
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment450
Start date15 November 2019
Primary completion30 April 2020
Estimated completion30 April 2020
Sites1 location across France

Conditions studied

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with Small Fiber Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Observational case-control study of small-fiber neuropathies, with regards on smoking and vitamin D deficiency and other possible causes.
    Fouchard M, Brenaut E, Genestet S, Ficheux AS, et al · · 2022 · cited 5× · PMID 36714112 · DOI 10.3389/fmed.2022.1051967

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Other recruiting trials for Small Fiber Neuropathy

Currently open trials in the same condition.

Other University Hospital, Brest trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing