<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/NCT03262584</url>
  </required_header>
  <id_info>
    <org_study_id>KDP-001</org_study_id>
    <nct_id>NCT03262584</nct_id>
  </id_info>
  <brief_title>Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients</brief_title>
  <official_title>Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karius, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karius, Inc.</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>
      The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens,&#xD;
      is more accurate than other noninvasive options and can report fungal genomic load.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS&#xD;
      analysis in a high-risk immunocompromised pediatric population.&#xD;
&#xD;
      Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal&#xD;
      tests if performed at the discretion of the treating provider (e.g. blood culture results,&#xD;
      radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results&#xD;
      or b-D-glucan (BG) results as evaluated via FDA-approved &quot;Fungitell&quot; assay). The Sponsor will&#xD;
      use these other fungal tests, in addition to clinical criterion, to classify subjects as&#xD;
      having possible, probable and proven IFD according to established criteria, and compare these&#xD;
      categories against results from NGS analysis.&#xD;
&#xD;
      Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic&#xD;
      load in subjects with positive results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">September 28, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>Incidence of positivity for fungal specific pathogens on NGS analysis</measure>
    <time_frame>7 months</time_frame>
    <description>We aim to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.</description>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Invasive Fungal Disease</condition>
  <condition>Fever and Neutropenia</condition>
  <condition>Invasive Fungal Infections</condition>
  <condition>Immunocompromised</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients treated at Ann &amp; Robert H. Lurie Children's Hospital of Chicago on the&#xD;
        hematology, oncology, neuro-oncology and stem cell transplant unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prolonged FN (≥96 hours) despite broad-spectrum antibiotic therapy with anticipated&#xD;
             delayed neutrophil recovery&#xD;
&#xD;
          -  Any findings that trigger the primary team to consider new fungal infection in a given&#xD;
             inpatient, such as abnormal imaging results, recrudescent fevers in the setting of&#xD;
             neutropenia or characteristic skin rashes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Those without concern for fungal infection or those currently being treated for a presumed&#xD;
        or documented fungal infection will not be recruited for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Armstrong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Invasive Fungal Infections</mesh_term>
    <mesh_term>Neutropenia</mesh_term>
  </condition_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/NCT03262584
org study id: KDP-001
nct id: NCT03262584
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Sponsor hypothesize that Next-generation Sequencing (NGS) can identify fungal pathogens,
      is more accurate than other noninvasive options and can report fungal genomic load.
The Sponsor aims to describe the incidence of positivity for fungal specific pathogens on NGS
      analysis in a high-risk immunocompromised pediatric population.

      Secondarily, the Sponsor will correlate results of the NGS analysis to other approved fungal
      tests if performed at the discretion of the treating provider (e.g. blood culture results,
      radiographic findings, biopsy results, bronchoalveolar lavage findings, galactomannan results
      or b-D-glucan (BG) results as evaluated via FDA-approved "Fungitell" assay). The Sponsor will
      use these other fungal tests, in addition to clinical criterion, to classify subjects as
      having possible, probable and proven IFD according to established criteria, and compare these
      categories against results from NGS analysis.

      Lastly, to quantitatively evaluate follow-up test results to determine fungal DNA genomic
      load in subjects with positive results.
observational model: Cohort
time perspective: Prospective
measure: Incidence of positivity for fungal specific pathogens on NGS analysis
time frame: 7 months
description: We aim to describe the incidence of positivity for fungal specific pathogens on NGS analysis in a high-risk immunocompromised pediatric population.
Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amy Armstrong, MD
role: Principal Investigator
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Invasive Fungal Infections
mesh term: Neutropenia