Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies

NCT05966350 | Completed

• 1 other identifier: IRBN742021/CHUSTE
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

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).

Conditions

Autoimmune Diseases

Keywords

Sensory neuronopathy; Sensory ganglionopathy; Auto-antibody; Anti-AGO antibody

Outcome Measures

Primary Outcomes (1)

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

  Sensitivity-specificity of Argonaute (AGO) antibodies screening

  2 Years

Secondary Outcomes (1)

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

  2 Years

Study Arms (3)

Sensory neuronopathies (SNN)

Patients with Sensory neuronopathies (SNN) will be included.

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)

another peripheral neuropathy

Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.

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)

dysimmune context without associated neuropathy.

Patient with dysimmune context without associated neuropathy will be included.

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)

Interventions

Diagnosis of sensitive neuronopathy - phase 1 DIAGNOSTIC_TEST

Search of positivity with anti-AGO antibodies test

Sensory neuronopathies (SNN); another peripheral neuropathy; dysimmune context without associated neuropathy.

Diagnosis of sensitive neuronopathy - phase 2 DIAGNOSTIC_TEST

Title of anti-AGO antibodies

Sensory neuronopathies (SNN); another peripheral neuropathy; dysimmune context without associated neuropathy.

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.

Sensory neuronopathies (SNN); another peripheral neuropathy; dysimmune context without associated neuropathy.

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).

Sensory neuronopathies (SNN); another peripheral neuropathy; dysimmune context without associated neuropathy.

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).

Sensory neuronopathies (SNN); another peripheral neuropathy; dysimmune context without associated neuropathy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sensory neuropathy

You may qualify if:

• Patients with sensory neuropathy

You may not qualify if:

• Patient not tested for anti-AGO antibody

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum collection for anti-FGFR3 antibody studies

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jean-Christophe ANTOINE, MDPHD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 28, 2023
• Study Start: May 27, 2021
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)