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/NCT05969379</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0712</org_study_id>
      <nct_id>NCT05969379</nct_id>
    </id_info>
    <brief_title>Investigational Biomarkers for Neurological Immune-related Adverse Events</brief_title>
    <acronym>NFL-ICI</acronym>
    <official_title>Genetic Predisposition, Inflammation, and Neurodegeneration Biomarkers in Patients With Neurological Adverse Events of Immune Checkpoint Inhibitors: Correlation With Clinical Phenotypes and Outcome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        Neurological immune-related adverse events (n-irAEs) are an emerging group of disorders of&#xD;
        patients with cancer treated with immune checkpoint inhibitors, presenting with heterogeneous&#xD;
        clinical manifestations and of uncertain outcome. Novel genetic, inflammatory, and&#xD;
        neurogenerative biomarkers could be associated with distinct phenotypes and different&#xD;
        outcomes. To test this hypothesis, the study will provide: a phenotypic characterization and&#xD;
        outcome assessment of patients with n-irAEs; the analysis of biomarkers of genetic&#xD;
        predisposition (HLA and other immunity-related genes), inflammation (serum and cerebrospinal&#xD;
        fluid [CSF] cytokines and autoantibodies, peripheral blood and CSF lymphocytes and other&#xD;
        immune cells, neuroimaging), neurodegeneration (serum and CSF neurofilaments, neuroimaging)&#xD;
        and their correlation with clinical features and outcome.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Analysis of neurofilaments</measure>
      <time_frame>At enrollment</time_frame>
      <description>Neurofilaments will be analysed by MSD.&#xD;
  Meso Scale Discovery Electrochemiluminescence (MSD) uses sandwich enzyme-linked immunosorbent assay (ELISA) method coupled with electro¬chemiluminescence (ECL) detection and plate array technology to provide highly sensitive and multiplexed detection of the analytes of interest (like neurofilaments) in a complex biological matrix.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Neurological Disease</condition>
    <arm_group>
      <arm_group_label>Patients with neurological immune-related adverse events (n-irAEs)</arm_group_label>
      <description>Patients developing neurological syndromes related to administration of any immune checkpoint inhibitors, including central nervous system disorders and neuromuscular toxicties</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>Analysis of biomarkers and their correlation with clinical characteristics and outcome</intervention_name>
      <description>This is a non-interventional study involving clinical data, neuroimaging analysis, and biological samples. Demographics and clinical data are collected in the database of the French Reference Centre. Additional or missing data will be obtained by contacting the referral physicians. All the neuroimages available will be analysed by dedicated software. Samples are already stored in biobank repositories and collected as part of &quot;good clinical practice&quot; in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the &quot;Centre de Ressources Biologiques des Hospices Civils de Lyon&quot; (CRB-HCL) (including tissue, cells or biological fluids). Additional samples for genetic testing will be collected upon explicit written consent.</description>
      <arm_group_label>Patients with neurological immune-related adverse events (n-irAEs)</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Serum, plasma EDTA, whole blood, CSF, PBMC&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients at least 18 years-old with a diagnosis of n-irAE&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of n-irAEs&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of an alternative diagnosis explaining the neurological syndrome&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Hôpital neurologique Pierre Wertheimer</name>
        <address>
          <city>Bron</city>
          <zip>69500</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>HONNORAT Jérôme, Pr</last_name>
        <phone>04 72 35 78 06</phone>
        <email>jerome.honnorat@chu-lyon.fr</email>
      </contact>
      <contact_backup>
        <last_name>PICARD Géraldine</last_name>
        <phone>04 72 35 58 42</phone>
        <email>geraldine.picard@chu-lyon.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Biomarkers</keyword>
    <keyword>autoimmunity</keyword>
    <keyword>immunotherapy side-effects</keyword>
    <keyword>immune checkpoint inhibitors</keyword>
    <keyword>neuroimmunology</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nervous System Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT05969379
  org study id: 69HCL23_0712
  nct id: NCT05969379
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Neurological immune-related adverse events (n-irAEs) are an emerging group of disorders of
        patients with cancer treated with immune checkpoint inhibitors, presenting with heterogeneous
        clinical manifestations and of uncertain outcome. Novel genetic, inflammatory, and
        neurogenerative biomarkers could be associated with distinct phenotypes and different
        outcomes. To test this hypothesis, the study will provide: a phenotypic characterization and
        outcome assessment of patients with n-irAEs; the analysis of biomarkers of genetic
        predisposition (HLA and other immunity-related genes), inflammation (serum and cerebrospinal
        fluid [CSF] cytokines and autoantibodies, peripheral blood and CSF lymphocytes and other
        immune cells, neuroimaging), neurodegeneration (serum and CSF neurofilaments, neuroimaging)
        and their correlation with clinical features and outcome.
  observational model: Cohort
  time perspective: Retrospective
  measure: Analysis of neurofilaments
  time frame: At enrollment
  description: Neurofilaments will be analysed by MSD.
  Meso Scale Discovery Electrochemiluminescence (MSD) uses sandwich enzyme-linked immunosorbent assay (ELISA) method coupled with electro¬chemiluminescence (ECL) detection and plate array technology to provide highly sensitive and multiplexed detection of the analytes of interest (like neurofilaments) in a complex biological matrix.
  arm group label: Patients with neurological immune-related adverse events (n-irAEs)
  description: Patients developing neurological syndromes related to administration of any immune checkpoint inhibitors, including central nervous system disorders and neuromuscular toxicties
  intervention type: Genetic
  intervention name: Analysis of biomarkers and their correlation with clinical characteristics and outcome
  description: This is a non-interventional study involving clinical data, neuroimaging analysis, and biological samples. Demographics and clinical data are collected in the database of the French Reference Centre. Additional or missing data will be obtained by contacting the referral physicians. All the neuroimages available will be analysed by dedicated software. Samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids). Additional samples for genetic testing will be collected upon explicit written consent.
  arm group label: Patients with neurological immune-related adverse events (n-irAEs)
  Serum, plasma EDTA, whole blood, CSF, PBMC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Nervous System Diseases