xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966350</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN742021/CHUSTE</org_study_id>
      <nct_id>NCT05966350</nct_id>
    </id_info>
    <brief_title>Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies</brief_title>
    <acronym>AGO</acronym>
    <official_title>Anti-Argonaute Antibodies for the Diagnosis of Sensory Neuronopathies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Argonaute (AGO) proteins have been described as the target of antibodies in several&#xD;
        autoimmune diseases including Sjögren Syndrome (SS). Sensory neuronopathies (SNN) are&#xD;
        disorders affecting neurons in the dorsal root ganglia that may depend on an inflammatory&#xD;
        process. However, identifying these cases needs the availability of specific biomarkers. The&#xD;
        aim of this study is to test the prevalence of anti-AGO antibodies in a population of&#xD;
        patients with Sensory neuronopathies (SNN) with and without associated autoimmune disease in&#xD;
        comparison with other peripheral neuropathies to determine how anti-AGO antibodies may help&#xD;
        the identification of potentially dysimmune Sensory neuronopathies (SNN).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sensory neuronopathies (SNN) are rare and debilitating diseases that fall under several&#xD;
        etiologies. Among them, dysimmune forms are the most frequent but very difficult to identify&#xD;
        when they do not occur in the context of associated systemic dysimmune disease (Sjögren&#xD;
        Syndrome (SS) syndrome) because only a biopsy of the epiphytically unthinkable posterior&#xD;
        spinal node would support the diagnosis. It is therefore necessary to have diagnostic&#xD;
        biological markers of these forms to consider rapid treatment before irreversible neuronal&#xD;
        degeneration.Using a protein-array technique, it has been showed that anti-FGFR3 antibodies&#xD;
        was one of these markers and that it was associated with a clinical picture that&#xD;
        differentiated from Sensory neuronopathies (SNN) without this antibody. Protein-array also&#xD;
        allowed to identify another potentially interesting antibody for the diagnosis of Sensitive&#xD;
        neuronopathies (NNS). This antibody recognizes the AGO1 protein. Anti-AGO1 antibodies have&#xD;
        been described in association with system autoimmune diseases and in particular lupus but not&#xD;
        in neurological diseases and more particularly in Sensory neuronopathies (SNN). The study&#xD;
        want to validate the diagnostic interest of these antibodies by testing the collection of&#xD;
        serums performed for studies on the anti-FGFR3 antibody and including patients with Sensory&#xD;
        neuronopathies (SNN) and as controls of patients with another form of neuropathy and subjects&#xD;
        with systemic autoimmune disease without peripheral neuropathy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 27, 2021</start_date>
    <completion_date type="Actual">January 27, 2023</completion_date>
    <primary_completion_date type="Actual">January 27, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies</measure>
      <time_frame>2 Years</time_frame>
      <description>Sensitivity-specificity of Argonaute (AGO) antibodies screening</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comparison of data between patients with anti-AGO antibodies versus patients without anti-AGO antibodies</measure>
      <time_frame>2 Years</time_frame>
      <description>Clinical pattern of the neuropathy in patients with anti-AGO antibodies versus patients without anti-AGO antibodies</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">630</enrollment>
    <condition>Autoimmune Diseases</condition>
    <arm_group>
      <arm_group_label>Sensory neuronopathies (SNN)</arm_group_label>
      <description>Patients with Sensory neuronopathies (SNN) will be included.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>another peripheral neuropathy</arm_group_label>
      <description>Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>dysimmune context without associated neuropathy.</arm_group_label>
      <description>Patient with dysimmune context without associated neuropathy will be included.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnosis of sensitive neuronopathy - phase 1</intervention_name>
      <description>Search of positivity with anti-AGO antibodies test</description>
      <arm_group_label>Sensory neuronopathies (SNN)</arm_group_label>
      <arm_group_label>another peripheral neuropathy</arm_group_label>
      <arm_group_label>dysimmune context without associated neuropathy.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnosis of sensitive neuronopathy - phase 2</intervention_name>
      <description>Title of anti-AGO antibodies</description>
      <arm_group_label>Sensory neuronopathies (SNN)</arm_group_label>
      <arm_group_label>another peripheral neuropathy</arm_group_label>
      <arm_group_label>dysimmune context without associated neuropathy.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Comparison with Chi2 method</intervention_name>
      <description>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.</description>
      <arm_group_label>Sensory neuronopathies (SNN)</arm_group_label>
      <arm_group_label>another peripheral neuropathy</arm_group_label>
      <arm_group_label>dysimmune context without associated neuropathy.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Comparison of data with parametric Test (T-test)</intervention_name>
      <description>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).</description>
      <arm_group_label>Sensory neuronopathies (SNN)</arm_group_label>
      <arm_group_label>another peripheral neuropathy</arm_group_label>
      <arm_group_label>dysimmune context without associated neuropathy.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Comparison of data with non-parametric test (ANNOVA)</intervention_name>
      <description>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).</description>
      <arm_group_label>Sensory neuronopathies (SNN)</arm_group_label>
      <arm_group_label>another peripheral neuropathy</arm_group_label>
      <arm_group_label>dysimmune context without associated neuropathy.</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Serum collection for anti-FGFR3 antibody studies&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with sensory neuropathy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with sensory neuropathy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient not tested for anti-AGO antibody&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jean-Christophe ANTOINE, MDPHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU SAINT-ETIENNE</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CHU Saint-Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <zip>42055</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sensory neuronopathy</keyword>
    <keyword>Sensory ganglionopathy</keyword>
    <keyword>Auto-antibody</keyword>
    <keyword>Anti-AGO antibody</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autoimmune Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966350
  org study id: IRBN742021/CHUSTE
  nct id: NCT05966350
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Sensitivity-specificity of Argonaute (AGO) antibodies for the diagnosis of sensory neuronopathies
  time frame: 2 Years
  description: Sensitivity-specificity of Argonaute (AGO) antibodies screening
  measure: Comparison of data between patients with anti-AGO antibodies versus patients without anti-AGO antibodies
  time frame: 2 Years
  description: Clinical pattern of the neuropathy in patients with anti-AGO antibodies versus patients without anti-AGO antibodies
  arm group label: Sensory neuronopathies (SNN)
  description: Patients with Sensory neuronopathies (SNN) will be included.
  arm group label: another peripheral neuropathy
  description: Patients with small fiber neuropathy, chronic polyradiculoneuritis or other axonal neuropathy) will be included.
  arm group label: dysimmune context without associated neuropathy.
  description: Patient with dysimmune context without associated neuropathy will be included.
  intervention type: Diagnostic Test
  intervention name: Diagnosis of sensitive neuronopathy - phase 1
  description: Search of positivity with anti-AGO antibodies test
  arm group label: Sensory neuronopathies (SNN)
  arm group label: another peripheral neuropathy
  arm group label: dysimmune context without associated neuropathy.
  intervention type: Diagnostic Test
  intervention name: Diagnosis of sensitive neuronopathy - phase 2
  description: Title of anti-AGO antibodies
  arm group label: Sensory neuronopathies (SNN)
  arm group label: another peripheral neuropathy
  arm group label: dysimmune context without associated neuropathy.
  intervention type: Other
  intervention name: Comparison with Chi2 method
  description: 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.
  arm group label: Sensory neuronopathies (SNN)
  arm group label: another peripheral neuropathy
  arm group label: dysimmune context without associated neuropathy.
  intervention type: Other
  intervention name: Comparison of data with parametric Test (T-test)
  description: 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).
  arm group label: Sensory neuronopathies (SNN)
  arm group label: another peripheral neuropathy
  arm group label: dysimmune context without associated neuropathy.
  intervention type: Other
  intervention name: Comparison of data with non-parametric test (ANNOVA)
  description: 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).
  arm group label: Sensory neuronopathies (SNN)
  arm group label: another peripheral neuropathy
  arm group label: dysimmune context without associated neuropathy.
  Serum collection for anti-FGFR3 antibody studies
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jean-Christophe ANTOINE, MDPHD
  role: Principal Investigator
  affiliation: CHU SAINT-ETIENNE
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Autoimmune Diseases
  sharing ipd: No