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Completed

NCT Number: NCT05966350

Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with sensory neuropathy

Exclusion criteria

  • Patient not tested for anti-AGO antibody

Treatment and study plan

Diagnosis of sensitive neuronopathy - phase 1

Diagnostic Test

Search of positivity with anti-AGO antibodies test

Diagnosis of sensitive neuronopathy - phase 2

Diagnostic Test

Title of anti-AGO antibodies

Comparison with Chi2 method

Other

Clinical data from positive Argonaute (AGO) patients (age, sex, type of neuropathy, clinical manifestations of neuropathy, electroneuromyography , evolution of neuropathy, presence of associated autoimmune disease, response to possible immunomodulatory treatment) will be compared with those of negative patients using a Chi2 method for qualitative data.

Comparison of data with parametric Test (T-test)

Other

Clinical data from positive Argonaute (AGO) patients (age, sex, type of neuropathy, clinical manifestations of neuropathy, electroneuromyography, evolution of neuropathy, presence of associated autoimmune disease, response to possible immunomodulatory treatment) will be compared with those of negative patients using a parametric test (T-test).

Comparison of data with non-parametric test (ANNOVA)

Other

Clinical data from positive Argonaute (AGO) patients (age, sex, type of neuropathy, clinical manifestations of neuropathy, electroneuromyography , evolution of neuropathy, presence of associated autoimmune disease, response to possible immunomodulatory treatment) will be compared with those of negative patients using a non-parametric (ANNOVA).

Primary outcomes

  1. Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies

    Time frame: 2 Years

    Sensitivity-specificity of Argonaute (AGO) antibodies screening

Secondary outcomes

  1. Comparison of data between patients with anti-AGO antibodies versus patients without anti-AGO antibodies

    Time frame: 2 Years

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: AGO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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