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Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies

Completed
Conditions
Autoimmune Diseases
Interventions
Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 1
Diagnostic Test: Diagnosis of sensitive neuronopathy - phase 2
Other: Comparison with Chi2 method
Other: Comparison of data with parametric Test (T-test)
Other: Comparison of data with non-parametric test (ANNOVA)
Registration Number
NCT05966350
Lead Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Brief Summary

Argonaute (AGO) proteins have been described as the target of antibodies in several autoimmune diseases including Sjögren Syndrome (SS). Sensory neuronopathies (SNN) are disorders affecting neurons in the dorsal root ganglia that may depend on an inflammatory process. However, identifying these cases needs the availability of specific biomarkers. The aim of this study is to test the prevalence of anti-AGO antibodies in a population of patients with Sensory neuronopathies (SNN) with and without associated autoimmune disease in comparison with other peripheral neuropathies to determine how anti-AGO antibodies may help the identification of potentially dysimmune Sensory neuronopathies (SNN).

Detailed Description

Sensory neuronopathies (SNN) are rare and debilitating diseases that fall under several etiologies. Among them, dysimmune forms are the most frequent but very difficult to identify when they do not occur in the context of associated systemic dysimmune disease (Sjögren Syndrome (SS) syndrome) because only a biopsy of the epiphytically unthinkable posterior spinal node would support the diagnosis. It is therefore necessary to have diagnostic biological markers of these forms to consider rapid treatment before irreversible neuronal degeneration.Using a protein-array technique, it has been showed that anti-FGFR3 antibodies was one of these markers and that it was associated with a clinical picture that differentiated from Sensory neuronopathies (SNN) without this antibody. Protein-array also allowed to identify another potentially interesting antibody for the diagnosis of Sensitive neuronopathies (NNS). This antibody recognizes the AGO1 protein. Anti-AGO1 antibodies have been described in association with system autoimmune diseases and in particular lupus but not in neurological diseases and more particularly in Sensory neuronopathies (SNN). The study want to validate the diagnostic interest of these antibodies by testing the collection of serums performed for studies on the anti-FGFR3 antibody and including patients with Sensory neuronopathies (SNN) and as controls of patients with another form of neuropathy and subjects with systemic autoimmune disease without peripheral neuropathy.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
630
Inclusion Criteria
  • Patients with sensory neuropathy
Exclusion Criteria
  • Patient not tested for anti-AGO antibody

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Sensory neuronopathies (SNN)Diagnosis of sensitive neuronopathy - phase 1Patients with Sensory neuronopathies (SNN) will be included.
Sensory neuronopathies (SNN)Comparison with Chi2 methodPatients with Sensory neuronopathies (SNN) will be included.
Sensory neuronopathies (SNN)Comparison of data with non-parametric test (ANNOVA)Patients with Sensory neuronopathies (SNN) will be included.
another peripheral neuropathyDiagnosis of sensitive neuronopathy - phase 1Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.
another peripheral neuropathyComparison of data with non-parametric test (ANNOVA)Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.
another peripheral neuropathyComparison with Chi2 methodPatients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.
Sensory neuronopathies (SNN)Comparison of data with parametric Test (T-test)Patients with Sensory neuronopathies (SNN) will be included.
another peripheral neuropathyComparison of data with parametric Test (T-test)Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.
dysimmune context without associated neuropathy.Diagnosis of sensitive neuronopathy - phase 1Patient with dysimmune context without associated neuropathy will be included.
Sensory neuronopathies (SNN)Diagnosis of sensitive neuronopathy - phase 2Patients with Sensory neuronopathies (SNN) will be included.
another peripheral neuropathyDiagnosis of sensitive neuronopathy - phase 2Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.
dysimmune context without associated neuropathy.Comparison with Chi2 methodPatient with dysimmune context without associated neuropathy will be included.
dysimmune context without associated neuropathy.Diagnosis of sensitive neuronopathy - phase 2Patient with dysimmune context without associated neuropathy will be included.
dysimmune context without associated neuropathy.Comparison of data with non-parametric test (ANNOVA)Patient with dysimmune context without associated neuropathy will be included.
dysimmune context without associated neuropathy.Comparison of data with parametric Test (T-test)Patient with dysimmune context without associated neuropathy will be included.
Primary Outcome Measures
NameTimeMethod
Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies2 Years

Sensitivity-specificity of Argonaute (AGO) antibodies screening

Secondary Outcome Measures
NameTimeMethod
Comparison of data between patients with anti-AGO antibodies versus patients without anti-AGO antibodies2 Years

Clinical pattern of the neuropathy in patients with anti-AGO antibodies versus patients without anti-AGO antibodies

Trial Locations

Locations (1)

CHU Saint-Etienne

🇫🇷

Saint-Étienne, France

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