Autoimmune DiseasesAGONCT05966350
Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies
An observational study of Autoimmune Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Diagnosis of sensitive neuronopathy - phase 1, Diagnosis of sensitive neuronopathy - phase 2 and Comparison with Chi2 method
- How many people
- 630 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2021to 27 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sensory neuropathy
Who may be able to join
- Patients with sensory neuropathy
Who cannot join
- Patient not tested for anti-AGO antibody
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Autoimmune Diseases
- Being tested
- Diagnosis of sensitive neuronopathy - phase 1, Diagnosis of sensitive neuronopathy - phase 2, Comparison with Chi2 method, Comparison of data with parametric Test (T-test), Comparison of data with non-parametric test (ANNOVA)
- Keywords
- Sensory neuronopathy, Sensory ganglionopathy, Auto-antibody, Anti-AGO antibody
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of sensitive neuronopathy - phase 1Diagnostic test
Search of positivity with anti-AGO antibodies test
Diagnosis of sensitive neuronopathy - phase 2Diagnostic test
Title of anti-AGO antibodies
Comparison with Chi2 methodOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Sensory neuronopathies (SNN) | Patients with Sensory neuronopathies (SNN) will be included. Receives: 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies
Sensitivity-specificity of Argonaute (AGO) antibodies screening
Measured: 2 Years
Secondary outcomes (1)
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
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start27 May 2021
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe ANTOINE, MDPHD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966350
- Sponsor's protocol ID
- IRBN742021/CHUSTE
- Acronym
- AGO
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies
- ClinicalTrials.gov ID
- NCT05966350
- Acronym / sponsor ID
- AGO / IRBN742021/CHUSTE
- Conditions
- Autoimmune Diseases
- Keywords
- Sensory neuronopathy, Sensory ganglionopathy, Auto-antibody, Anti-AGO antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sensory neuronopathies (SNN) | – | 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)Patients with Sensory neuronopathies (SNN) will be included. |
| another peripheral neuropathy | – | 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)Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included. |
| dysimmune context without associated neuropathy. | – | 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)Patient with dysimmune context without associated neuropathy will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sensory neuropathy
Key inclusion criteria (1 listed)
- Patients with sensory neuropathy
Key exclusion criteria (1 listed)
- Patient not tested for anti-AGO antibody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of sensitive neuronopathy - phase 1Search of positivity with anti-AGO antibodies test | Diagnostic test | Sensory neuronopathies (SNN), another peripheral neuropathy, dysimmune context without associated neuropathy. |
| Diagnosis of sensitive neuronopathy - phase 2Title of anti-AGO antibodies | Diagnostic test | Sensory neuronopathies (SNN), another peripheral neuropathy, dysimmune context without associated neuropathy. |
| Comparison with Chi2 methodClinical 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. | Other | Sensory neuronopathies (SNN), another peripheral neuropathy, dysimmune context without associated neuropathy. |
| 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). | Other | Sensory neuronopathies (SNN), another peripheral neuropathy, dysimmune context without associated neuropathy. |
| 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). | Other | Sensory neuronopathies (SNN), another peripheral neuropathy, dysimmune context without associated neuropathy. |
Primary outcome
Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies
Time frame: 2 Years
Sensitivity-specificity of Argonaute (AGO) antibodies screening
1 secondary outcome
Comparison of data between patients with anti-AGO antibodies versus patients without anti-AGO antibodies
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe ANTOINE, MDPHD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.