Small Fiber NeuropathyEtioNPFNCT04170205
Causes Associated With Small Fiber Neuropathy (SFN).
An observational study of Small Fiber Neuropathy, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Fiber Neuropathy
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2019to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical symptomatology in favour of SFN who have been subjected to skin histological examination for SFN
Who may be able to join
- 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
Who cannot join
- Under age of majority (<18 years old)
- Patient not followed at Brest University Hospital
- Refusal to participate to the study
Trial locations and contacts
1 site in 1 country.
Maxime FOUCHARD contact
France1 site
CHRU de Brest
Brest, 29609
Laurent Misery, laurent.misery@chu-brest.fr
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Small Fiber Neuropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start15 Nov 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170205
- Sponsor's protocol ID
- 29BRC19. 0218 (EtioNPF)
- Acronym
- EtioNPF
- Status last verified
- Oct 2019
- First submitted
- 13 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Causes Associated With Small Fiber Neuropathies.
- ClinicalTrials.gov ID
- NCT04170205
- Acronym / sponsor ID
- EtioNPF / 29BRC19. 0218 (EtioNPF)
- Conditions
- Small Fiber Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Nov 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical symptomatology in favour of SFN who have been subjected to skin histological examination for SFN
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Under age of majority (<18 years old)
- Patient not followed at Brest University Hospital
- Refusal to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of etiologies associated with SFN
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Small Fiber Neuropathy
Recruiting
Magnetic Brain Stimulation in Small Fiber Neuropathy
Small Fiber Neuropathy
Enrolling by invitation
Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy
Small Fiber Neuropathy
Not yet recruitingPhase 4
Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy
Neuropathy, Small Fiber, Diabete Mellitus
RecruitingPhase 1/2
Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
Chronic Neuropathic Pain
RecruitingObservational study
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
Primary Sjögren Syndrome, Small Fiber Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime FOUCHARD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Fiber Neuropathy, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent MISERY (+330298223315, laurent.misery@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of etiologies associated with SFN (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019; AzTrials last refreshed its copy on 1 Nov 2026.