<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/NCT03275610</url>
  </required_header>
  <id_info>
    <org_study_id>ORTHO-01</org_study_id>
    <nct_id>NCT03275610</nct_id>
  </id_info>
  <brief_title>Genetic Markers of Patients With History of Pulmonary Embolism Post Total Joint Arthroplasty</brief_title>
  <official_title>Risk Stratification Using Genetic Markers of Patients With a History of Pulmonary Embolism Post Total Hip or Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</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>
      This study seeks to uncover potential genetic determinants of pulmonary embolism (PE). Our&#xD;
      translational goal is to ultimately identify certain genetic markers that will allow us to&#xD;
      stratify patients in terms of their PE risk post total knee or total hip arthroplasty. The&#xD;
      clinical implications for this study would allow for better patient care by lowering the risk&#xD;
      of post-operative bleeding while still preventing symptomatic PEs and deep vein thromboses&#xD;
      (DVTs). We look to sample patients who have a history of PE after undergoing total knee or&#xD;
      total hip arthroplasty. We will sample these patients' blood DNA for a set of DNA genetic&#xD;
      markers. To do so, we will utilize the Taqman assay, which is a PCR-based 5'-nuclease allelic&#xD;
      discrimination assay to determine single nucleotide polymorphism (SNP) genotypes at specified&#xD;
      loci. The region flanking the SNP is amplified using two allele-specific fluorescent probes,&#xD;
      allowing for the detection of each allele in a single tube. Using this assay, there is no&#xD;
      post-PCR processing because the probes are included in the PCR reaction (Hui). Using this&#xD;
      approach, we will measure the frequency of genetic mutations in patients who have developed a&#xD;
      PE after a total joint arthroplasty. This data would then be used to perform a prospective&#xD;
      study to determine a subset of genetic markers that can definitively be used to risk stratify&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">April 24, 2017</start_date>
  <completion_date type="Anticipated">April 23, 2026</completion_date>
  <primary_completion_date type="Anticipated">April 23, 2026</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>Identification of Genetic Mutations</measure>
    <time_frame>6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty</time_frame>
    <description>identify the frequency of genetic mutations in patients who have developed a PE after a total joint or total hip arthroplasty</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pulmonary Embolism</condition>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>5 mL of blood withdrawn from patients with history of pulmonary embolism post total hip arthroplasty or total joint arthroplasty</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Established patients with a history of Pulmonary Embolism Post Total Hip Arthroplasty or&#xD;
        Post Knee Arthroplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with a history of Pulmonary Embolism and Total Hip Arthroplasty or Total Knee&#xD;
             Arthroplasty, between the ages of 18 and 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jay R Lieberman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Jay R. Lieberman, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03275610
org study id: ORTHO-01
nct id: NCT03275610
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to uncover potential genetic determinants of pulmonary embolism (PE). Our
      translational goal is to ultimately identify certain genetic markers that will allow us to
      stratify patients in terms of their PE risk post total knee or total hip arthroplasty. The
      clinical implications for this study would allow for better patient care by lowering the risk
      of post-operative bleeding while still preventing symptomatic PEs and deep vein thromboses
      (DVTs). We look to sample patients who have a history of PE after undergoing total knee or
      total hip arthroplasty. We will sample these patients' blood DNA for a set of DNA genetic
      markers. To do so, we will utilize the Taqman assay, which is a PCR-based 5'-nuclease allelic
      discrimination assay to determine single nucleotide polymorphism (SNP) genotypes at specified
      loci. The region flanking the SNP is amplified using two allele-specific fluorescent probes,
      allowing for the detection of each allele in a single tube. Using this assay, there is no
      post-PCR processing because the probes are included in the PCR reaction (Hui). Using this
      approach, we will measure the frequency of genetic mutations in patients who have developed a
      PE after a total joint arthroplasty. This data would then be used to perform a prospective
      study to determine a subset of genetic markers that can definitively be used to risk stratify
      patients.
observational model: Cohort
time perspective: Prospective
measure: Identification of Genetic Mutations
time frame: 6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty
description: identify the frequency of genetic mutations in patients who have developed a PE after a total joint or total hip arthroplasty
intervention type: Genetic
intervention name: Blood sample
description: 5 mL of blood withdrawn from patients with history of pulmonary embolism post total hip arthroplasty or total joint arthroplasty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jay R Lieberman, MD
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Jay R. Lieberman, MD
investigator title: Professor
mesh term: Pulmonary Embolism
mesh term: Embolism
sharing ipd: No