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Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies

NCT ID: NCT05966350

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-27

Study Completion Date

2023-01-27

Brief Summary

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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

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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.

Conditions

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Autoimmune Diseases

Keywords

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Sensory neuronopathy Sensory ganglionopathy Auto-antibody Anti-AGO antibody

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sensory neuronopathies (SNN)

Patients with Sensory neuronopathies (SNN) will be included.

Diagnosis of sensitive neuronopathy - phase 1

Intervention Type DIAGNOSTIC_TEST

Search of positivity with anti-AGO antibodies test

Diagnosis of sensitive neuronopathy - phase 2

Intervention Type DIAGNOSTIC_TEST

Title of anti-AGO antibodies

Comparison with Chi2 method

Intervention Type 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)

Intervention Type 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)

Intervention Type 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).

another peripheral neuropathy

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

Diagnosis of sensitive neuronopathy - phase 1

Intervention Type DIAGNOSTIC_TEST

Search of positivity with anti-AGO antibodies test

Diagnosis of sensitive neuronopathy - phase 2

Intervention Type DIAGNOSTIC_TEST

Title of anti-AGO antibodies

Comparison with Chi2 method

Intervention Type 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)

Intervention Type 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)

Intervention Type 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).

dysimmune context without associated neuropathy.

Patient with dysimmune context without associated neuropathy will be included.

Diagnosis of sensitive neuronopathy - phase 1

Intervention Type DIAGNOSTIC_TEST

Search of positivity with anti-AGO antibodies test

Diagnosis of sensitive neuronopathy - phase 2

Intervention Type DIAGNOSTIC_TEST

Title of anti-AGO antibodies

Comparison with Chi2 method

Intervention Type 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)

Intervention Type 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)

Intervention Type 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).

Interventions

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Diagnosis of sensitive neuronopathy - phase 1

Search of positivity with anti-AGO antibodies test

Intervention Type DIAGNOSTIC_TEST

Diagnosis of sensitive neuronopathy - phase 2

Title of anti-AGO antibodies

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

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).

Intervention Type OTHER

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with sensory neuropathy

Exclusion Criteria

* Patient not tested for anti-AGO antibody
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe ANTOINE, MDPHD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN742021/CHUSTE

Identifier Type: -

Identifier Source: org_study_id