<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/NCT03014284</url>
  </required_header>
  <id_info>
    <org_study_id>CTMS 16-0101</org_study_id>
    <secondary_id>HSC20160555H</secondary_id>
    <nct_id>NCT03014284</nct_id>
  </id_info>
  <brief_title>Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis</brief_title>
  <official_title>Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a simple tissue collection study with no therapeutic intent. Colon tissues will be&#xD;
      taken from standard of care procedures. Tissues will be tested for their functions,&#xD;
      expression of immune co-signaling molecules and reactions to transduction with recombinant&#xD;
      Listeria vectors to assess effects on expression of B7-H1 and cytokines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Military collaborator sample supplier was transferred, no samples obtained&#xD;
  </why_stopped>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Actual">September 12, 2018</completion_date>
  <primary_completion_date type="Actual">September 12, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Expression of B7-H1</measure>
    <time_frame>Baseline tissue collection</time_frame>
    <description>To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Colitis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Obtain human colon tissue for ex vivo studies of B7-H1 expression, signaling pathways and&#xD;
      effects of recombinant Listeria vectors.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 50% of patients are expected to be Caucasian, about 40% Hispanic and the&#xD;
        remainder African American and other minorities. The investigators anticipate that subjects&#xD;
        will range in age from 18 years old and older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide informed consent (or have consent provided through a guardian)&#xD;
&#xD;
          -  No immune-modulating drug use during study or within 30 days prior to enrollment&#xD;
&#xD;
          -  Having colon material collected as part of standard of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent (or have consent provided through a guardian)&#xD;
&#xD;
          -  Not having colon material collected as part of standard of care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tyler Curiel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Health Science Center at the Cancer Therapy and Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Therapy &amp; Research Center at UTHSCSA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>September 13, 2018</last_update_submitted>
  <last_update_submitted_qc>September 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tissue collection</keyword>
  <keyword>colonoscopic surgical procedures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Colitis</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/NCT03014284
org study id: CTMS 16-0101
secondary id: HSC20160555H
nct id: NCT03014284
lead sponsor: 
has dmc: No
This is a simple tissue collection study with no therapeutic intent. Colon tissues will be
      taken from standard of care procedures. Tissues will be tested for their functions,
      expression of immune co-signaling molecules and reactions to transduction with recombinant
      Listeria vectors to assess effects on expression of B7-H1 and cytokines.
observational model: Case-Only
time perspective: Prospective
measure: Expression of B7-H1
time frame: Baseline tissue collection
description: To assess the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues
Obtain human colon tissue for ex vivo studies of B7-H1 expression, signaling pathways and
      effects of recombinant Listeria vectors.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tyler Curiel, MD
role: Principal Investigator
affiliation: University of Texas Health Science Center at the Cancer Therapy and Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Colitis