Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies

Autoimmune Diseases Clinical Trial

— AGO  

Official title:

Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966350
• Other study ID #: IRBN742021/CHUSTE
• Status: Completed
• Start date: May 27, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with sensory neuropathy

Exclusion Criteria:

• Patient not tested for anti-AGO antibody

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Diagnostic Test:
• Diagnosis of sensitive neuronopathy - phase 1
Search of positivity with anti-AGO antibodies test
• Diagnosis of sensitive neuronopathy - phase 2
Title of anti-AGO antibodies

Other:
• Comparison with Chi2 method
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)
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)
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).

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies	Sensitivity-specificity of Argonaute (AGO) antibodies screening	2 Years
Secondary	Comparison of data between patients with anti-AGO antibodies versus patients without anti-AGO antibodies	Clinical pattern of the neuropathy in patients with anti-AGO antibodies versus patients without anti-AGO antibodies	2 Years