<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/NCT03302325</url>
  </required_header>
  <id_info>
    <org_study_id>102718</org_study_id>
    <nct_id>NCT03302325</nct_id>
  </id_info>
  <brief_title>Circulating Tumor DNA as Liquid Biopsy in Patients With Stage IV Solid Tumors, a Feasibility Study at MUSC HCC</brief_title>
  <official_title>Circulating Tumor DNA as Liquid Biopsy in Patients With Stage IV Solid Tumors, a Feasibility Study at MUSC HCC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</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>
      1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from&#xD;
           plasma of stage IV cancer patients at HCC.&#xD;
&#xD;
        2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when&#xD;
           available, with those of primary tumor and metastasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to&#xD;
      determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic&#xD;
      acid. DNA contains information that determines in part the traits, such as eye color, height,&#xD;
      or disease risk, that are passed on from parent to child. This reaction will be measured by&#xD;
      studying patient blood that will be collected before and during treatment until there is&#xD;
      disease progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">January 6, 2020</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>Detecting specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in patients' ctDNA longitudinal samples through treatment, and when available, of primary tumor and metastasis.</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Solid Tumor, Adult</condition>
  <arm_group>
    <arm_group_label>Stage IV solid tumors</arm_group_label>
    <description>adult patients with stage IV cancer that are starting a new line of treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>research blood draws</intervention_name>
    <description>Twenty-five mL of peripheral blood (PB) will be collected for research. Blood will be collected in EDTA tubes and used to isolate ctDNA. For each subject we will request that he/she contribute 25 mL of plasma no more frequently than every 6 weeks, and at same time of standard of care blood draws and routine clinic visit, and for no more than 3 times (including baseline and end of study).</description>
    <arm_group_label>Stage IV solid tumors</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      circulating tumor DNA (ctDNA) in the blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with stage IV cancer that start a new line of treatment and agree to have&#xD;
        blood drawn&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of stage IV malignancy, including any advanced solid tumors&#xD;
             (including lymphoma)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-3&#xD;
&#xD;
          -  Life expectancy ≥ 3 months&#xD;
&#xD;
          -  Patients must be able to provide consent&#xD;
&#xD;
          -  Patients can be enrolled in other interventional clinical trials&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Age &lt; 18-year-old&#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>Antonio Giordano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>January 29, 2020</last_update_submitted>
  <last_update_submitted_qc>January 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stage IV solid tumor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03302325
org study id: 102718
nct id: NCT03302325
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from
           plasma of stage IV cancer patients at HCC.

        2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when
           available, with those of primary tumor and metastasis.
The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to
      determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic
      acid. DNA contains information that determines in part the traits, such as eye color, height,
      or disease risk, that are passed on from parent to child. This reaction will be measured by
      studying patient blood that will be collected before and during treatment until there is
      disease progression.
observational model: Case-Only
time perspective: Prospective
measure: Detecting specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.
time frame: 24 months
measure: Changes in patients' ctDNA longitudinal samples through treatment, and when available, of primary tumor and metastasis.
time frame: 24 months
arm group label: Stage IV solid tumors
description: adult patients with stage IV cancer that are starting a new line of treatment
intervention type: Procedure
intervention name: research blood draws
description: Twenty-five mL of peripheral blood (PB) will be collected for research. Blood will be collected in EDTA tubes and used to isolate ctDNA. For each subject we will request that he/she contribute 25 mL of plasma no more frequently than every 6 weeks, and at same time of standard of care blood draws and routine clinic visit, and for no more than 3 times (including baseline and end of study).
arm group label: Stage IV solid tumors
circulating tumor DNA (ctDNA) in the blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Giordano, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms