<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/NCT03767712</url>
  </required_header>
  <id_info>
    <org_study_id>2016-00895, me16Potlukova</org_study_id>
    <nct_id>NCT03767712</nct_id>
  </id_info>
  <brief_title>Trauma as a Trigger for Autoimmunity</brief_title>
  <acronym>TATA</acronym>
  <official_title>Trauma as a Trigger for Autoimmunity - a Single Centre Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with&#xD;
      consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on&#xD;
      the development of autoimmunity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project represents a unique study of the influence of trauma on the immune system. It&#xD;
      addresses the question whether an excess of apoptotic/necrotic cells can induce an at least&#xD;
      transient autoimmune phenomena in humans. If the hypothesis of a transient induction of&#xD;
      autoimmunity by trauma proves to be correct, this study will provide a novel insight into the&#xD;
      pathogenesis of autoimmune diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2016</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 23, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ANA</measure>
    <time_frame>Preoperative (1-2 days preoperative) and 12 weeks postoperative</time_frame>
    <description>Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ANA</measure>
    <time_frame>6 weeks postoperative and 12 weeks postoperative and 12 months postoperative</time_frame>
    <description>Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)</measure>
    <time_frame>Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative</time_frame>
    <description>serum level of Anti-dsDNA (U/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Antibody level against Anti-Cardiolipin</measure>
    <time_frame>Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative</time_frame>
    <description>serum level of Anti-Cardiolipin (U/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Antibody level against complement component C1q (Anti-C1q)</measure>
    <time_frame>Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative</time_frame>
    <description>serum level of C1q (U/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)</measure>
    <time_frame>Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative</time_frame>
    <description>serum level of Anti-SSA/Ro (U/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells</measure>
    <time_frame>Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative</time_frame>
    <description>Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells (cells/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)</measure>
    <time_frame>Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative</time_frame>
    <description>Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Autoimmunity</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.</intervention_name>
    <description>To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum samples of each subject in a form of biobank (TATA-Biobank) in order to allow future&#xD;
      analyses (e.g. emerging biomarkers in relation to trauma).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute pertrochanteric fracture in whom an operation (gamma-nail&#xD;
        osteosynthesis) is planned at the University Hospital Basel.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pertrochanteric femoral fracture (≤7 days)&#xD;
&#xD;
          -  planned gamma nail osteosynthesis&#xD;
&#xD;
          -  ability to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe hepatic and renal failure&#xD;
&#xD;
          -  current active oncological disease&#xD;
&#xD;
          -  current immunosuppressive or biological therapy&#xD;
&#xD;
          -  known systemic autoimmune disease&#xD;
&#xD;
          -  foreseeable lack of complete follow-up (e.g. due to generally poor health)&#xD;
&#xD;
          -  cognitive impairment (delirium, dementia, alteration of consciousness)&#xD;
&#xD;
          -  insufficient knowledge of project language&#xD;
&#xD;
          -  pregnancy&#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>Eliska Potlukova, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Innere Medizin, Universitätsspital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>trauma</keyword>
  <keyword>immunological reaction to trauma</keyword>
  <keyword>pertrochanteric femoral fracture</keyword>
  <keyword>antinuclear antibodies</keyword>
  <keyword>activation of innate immunity</keyword>
  <keyword>adaptive immunity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Antinuclear</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03767712
org study id: 2016-00895, me16Potlukova
nct id: NCT03767712
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To analyse the immunological reaction to Trauma (pertrochanteric femoral fracture with
      consequent osteosynthesis) in the first weeks up to one year postoperatively with focus on
      the development of autoimmunity.
This project represents a unique study of the influence of trauma on the immune system. It
      addresses the question whether an excess of apoptotic/necrotic cells can induce an at least
      transient autoimmune phenomena in humans. If the hypothesis of a transient induction of
      autoimmunity by trauma proves to be correct, this study will provide a novel insight into the
      pathogenesis of autoimmune diseases.
observational model: Cohort
time perspective: Prospective
measure: Change in ANA
time frame: Preoperative (1-2 days preoperative) and 12 weeks postoperative
description: Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy = indirect immunofluorescence on a Hep-2 cell line). In order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used (NOVA View, INOVA Diagnostics
measure: Change in ANA
time frame: 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
description: Fluorescence Index (FI) for ANA measurement (automated digital fluorescence microscopy)
measure: Change in Antibody level against double stranded deoxyribonucleic acid (Anti-dsDNA)
time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
description: serum level of Anti-dsDNA (U/ml)
measure: Change in Antibody level against Anti-Cardiolipin
time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
description: serum level of Anti-Cardiolipin (U/ml)
measure: Change in Antibody level against complement component C1q (Anti-C1q)
time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
description: serum level of C1q (U/ml)
measure: Change in Antibody level against Sjögren's-syndrome-related antigen A (Anti-SSA/Ro)
time frame: Preoperative (1-2 days preoperative) and 6 weeks postoperative and 12 weeks postoperative and 12 months postoperative
description: serum level of Anti-SSA/Ro (U/ml)
measure: Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells
time frame: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
description: Change in proportion of immune cells (Plasmablasts, regulatory T cell (T-regs), total Cluster of Differentiation (CD)4+, CD8+, CD19+, Natural killer (NK) cells (cells/ml)
measure: Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)
time frame: Preoperative (1-2 days preoperative) and 3-4 days postoperative and 6 weeks postoperative and 12 weeks postoperative
description: Change in serum levels of cytokines (Interleukin (IL)-6 , IL-10, IL-18, Tumor necrosis factor (TNF)-a , Tumor necrosis factor receptor two (TNF-RII)
intervention type: Diagnostic Test
intervention name: Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.
description: To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)
serum samples of each subject in a form of biobank (TATA-Biobank) in order to allow future
      analyses (e.g. emerging biomarkers in relation to trauma).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eliska Potlukova, PhD
role: Principal Investigator
affiliation: Klinik für Innere Medizin, Universitätsspital Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Autoimmune Diseases
mesh term: Antibodies
mesh term: Antibodies, Antinuclear