<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/NCT04459468</url>
  </required_header>
  <id_info>
    <org_study_id>STU-2019-1758</org_study_id>
    <nct_id>NCT04459468</nct_id>
  </id_info>
  <brief_title>Identify Proteomic Biomarkers for Outcome Prediction of Lipiodol TACE Treatment</brief_title>
  <acronym>Lipiodol TACE</acronym>
  <official_title>Identify Proteomic Biomarkers for Outcome Prediction of Lipiodol TACE Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will enroll patients being planned for TACE, obtain blood samples pre and post&#xD;
      TACE for biomarker identification using bead based X-aptamer library. No intervention is&#xD;
      planned.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-blinded, multi-arm study. Patients at 18 - 70 years old with liver&#xD;
      cancer will be enrolled.&#xD;
&#xD;
      The approach is to identify novel proteomic biomarkers for HCC patients treated with Lipiodol&#xD;
      TACE using beads-based X-aptamer library, then validate and create a biomarker panel that can&#xD;
      be used to predict the outcome of HCC post-Lipiodol TACE treatment.&#xD;
&#xD;
      Lipiodol TACE will be done as standard of care and the only thing done as research will be&#xD;
      blood draws pre and post-TACE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 4, 2022</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients</measure>
    <time_frame>2 years</time_frame>
    <description>X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients.</measure>
    <time_frame>2 years</time_frame>
    <description>X-aptamer identified biomarker to predict overall survival after treatment with Lipoidol TACE .</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>HCC for Lipiodol TACE</arm_group_label>
    <description>These patients will standard of care Lipiodol TACE treatment. No research intervention is planned</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Healthy controls from public database</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HCC patients</arm_group_label>
    <description>HCC patients will be used for biomarker validation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lipiodol</intervention_name>
    <description>Lipiodol TACE procedure</description>
    <arm_group_label>HCC for Lipiodol TACE</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Pre and Post-TACE blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with HCC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
          2. Male or female aged 18-70years.&#xD;
&#xD;
          3. Diagnosed with primary or metastatic liver cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects who have received chemotherapy, radiation or surgery for HCC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Claire Starcke, BS</last_name>
    <phone>214-648-8152</phone>
    <email>Charlton.Starcke@UTSouthwestern.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claire Starcke, BS</last_name>
      <phone>214-648-8152</phone>
      <email>Charlton.Starcke@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Anil Pillai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Anil Pillai</investigator_full_name>
    <investigator_title>ASSOC PROFESSOR - Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethiodized Oil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04459468
org study id: STU-2019-1758
nct id: NCT04459468
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study will enroll patients being planned for TACE, obtain blood samples pre and post
      TACE for biomarker identification using bead based X-aptamer library. No intervention is
      planned.
This is a prospective, non-blinded, multi-arm study. Patients at 18 - 70 years old with liver
      cancer will be enrolled.

      The approach is to identify novel proteomic biomarkers for HCC patients treated with Lipiodol
      TACE using beads-based X-aptamer library, then validate and create a biomarker panel that can
      be used to predict the outcome of HCC post-Lipiodol TACE treatment.

      Lipiodol TACE will be done as standard of care and the only thing done as research will be
      blood draws pre and post-TACE.
observational model: Case-Control
time perspective: Prospective
measure: Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients
time frame: 2 years
description: X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP.
measure: Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients.
time frame: 2 years
description: X-aptamer identified biomarker to predict overall survival after treatment with Lipoidol TACE .
arm group label: HCC for Lipiodol TACE
description: These patients will standard of care Lipiodol TACE treatment. No research intervention is planned
arm group label: Healthy controls
description: Healthy controls from public database
arm group label: HCC patients
description: HCC patients will be used for biomarker validation.
intervention type: Drug
intervention name: Lipiodol
description: Lipiodol TACE procedure
arm group label: HCC for Lipiodol TACE
Pre and Post-TACE blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Claire Starcke, BS
phone: 214-648-8152
email: Charlton.Starcke@UTSouthwestern.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Anil Pillai
investigator title: ASSOC PROFESSOR - Radiology
mesh term: Carcinoma, Hepatocellular
mesh term: Ethiodized Oil
sharing ipd: Undecided