Causes Associated With Small Fiber Neuropathy (SFN). (EtioNPF)

Retrospective Study of Causes Associated With Small Fiber Neuropathies.

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.

Study Overview

• Status: Unknown
• Conditions: Small Fiber Neuropathy

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Small Fiber Neuropathy
• Other Study ID Numbers: 29BRC19. 0218 (EtioNPF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning one year and ending five years following the publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No