Causes Associated With Small Fiber Neuropathy (SFN).

NCT04170205 | Unknown

• 1 other identifier: 29BRC19. 0218 (EtioNPF)
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Fiber Neuropathy

Outcome Measures

Primary Outcomes (1)

• Prevalence of etiologies associated with SFN

  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

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical symptomatology in favour of SFN who have been subjected to skin histological examination for SFN

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Laurent MISERY

CONTACT

+330298223315; laurent.misery@chu-brest.fr

Maxime FOUCHARD

CONTACT

maxime.fouchard@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 20, 2019
• Study Start: November 15, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)