<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/NCT02978118</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00076768</org_study_id>
    <nct_id>NCT02978118</nct_id>
  </id_info>
  <brief_title>Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immune Checkpoint Inhibitors in Genitourinary Malignancies (CTC Immune Based Biomarkers)</brief_title>
  <official_title>Exploring Relevant Immune-based Biomarkers and Circulating Tumor Cells During Treatment With Immune Checkpoint Inhibitors in Genitourinary Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study purpose of this study is to describe peripheral circulating immune cell&#xD;
      profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell&#xD;
      carcinoma and urothelial carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    change in PI and possibly funding&#xD;
  </why_stopped>
  <start_date type="Actual">March 7, 2017</start_date>
  <completion_date type="Anticipated">December 2023</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>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of T-cells before and after treatment with immune therapies</measure>
    <time_frame>Baseline and Disease progression (up to two years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of B-cells before and after treatment with immune therapies</measure>
    <time_frame>Baseline and Disease progression (up to two years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the number of myeloid cells before and after treatment with immune therapies</measure>
    <time_frame>Baseline and Disease progression (up to two years)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with detectable circulating tumor cells (CTCs)</measure>
    <time_frame>Disease progression (up to two years)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The prevalence of tumor-associated macrophages for all subjects at baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in CTCs over time</measure>
    <time_frame>Baseline, week 4, week 8, week 12 and progression (up to two years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD</measure>
    <time_frame>Disease progression (up to two years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in tumor burden over time measured by RECIST</measure>
    <time_frame>Baseline, Week 12, Progression (up to two years)</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Carcinoma, Renal Cell</condition>
  <condition>Carcinoma, Urothelial</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Subjects in Group A (patients with metastatic renal cell carcinoma starting immune therapy) will have PBMC, plasma storage and analysis for immune cell profiles at baseline, 4 weeks, 12 weeks, and upon disease progression on treatment. Patients will have CTC assessment at baseline, 4 weeks, and upon disease progression. Urinary specimens will be collected at baseline, 4 weeks, 12 weeks, and disease progression. Fecal specimens will be collected at baseline (within 3 days of cycle 1 day 1), 4 weeks, and upon disease progression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Subjects in Group B (patients with metastatic urothelial carcinoma) will have PBMC and plasma storage and analysis for immune cell profiles at baseline, 4 weeks, 12 weeks, and upon disease progression on treatment. Patients will have CTC assessment at baseline, 4 weeks, and disease progression. Urinary specimens will be collected at baseline, 4 weeks, 12 weeks, and disease progression. Fecal specimens will be collected at baseline (within 3 days of cycle 1 day 1), 4 weeks, and upon disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Immune cell and CTC detection procedures</intervention_name>
    <description>Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Duke Cancer Institute Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group A:&#xD;
&#xD;
        Patients will be eligible for inclusion in this study if ALL of the following criteria&#xD;
        apply:&#xD;
&#xD;
          1. Histologically confirmed diagnosis of renal cell carcinoma. Clear cell and non-clear&#xD;
             cell carcinoma (such as papillary, chromophobe, collecting duct, and medullary)&#xD;
             allowed.&#xD;
&#xD;
          2. Evidence of metastatic disease in any site on most recent imaging scan&#xD;
&#xD;
          3. Planned initiation of treatment with immune modulatory agent targeting any of the&#xD;
             following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3&#xD;
&#xD;
          4. Age &gt; 18 years.&#xD;
&#xD;
          5. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Group B:&#xD;
&#xD;
        Patients will be eligible for inclusion in this study if ALL of the following criteria&#xD;
        apply:&#xD;
&#xD;
          1. Histologically confirmed diagnosis of urothelial carcinoma. Non-transitional cell&#xD;
             carcinoma (such as adenocarcinoma and squamous cell carcinoma) allowed.&#xD;
&#xD;
          2. Evidence of metastatic disease in any site on most recent imaging scan&#xD;
&#xD;
          3. Planned initiation of treatment with immune modulatory agent targeting any of the&#xD;
             following: PD-1, PD-L1, CTLA-4, CD27, OX40, or LAG3&#xD;
&#xD;
          4. Age &gt; 18 years.&#xD;
&#xD;
          5. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A patient will not be eligible for inclusion in this study if any of the following criteria&#xD;
        apply:&#xD;
&#xD;
          1. History of intercurrent or past medical or psychiatric illness that would make&#xD;
             participation in a blood drawing protocol difficult or not feasible at the discretion&#xD;
             of the principal investigator or co-investigator(s).&#xD;
&#xD;
          2. Treatment with systemic steroids of any dose or formulation (including hydrocortisone,&#xD;
             prednisone, methylprednisolone (Solumedrol), dexamethasone), within 4 weeks of consent&#xD;
             or planned initiation of steroids after consent (unplanned steroid initiation for&#xD;
             treatment of immune related adverse events is allowed). Chronic treatment with&#xD;
             steroids for physiological replacement for adrenal insufficiency is allowed.&#xD;
&#xD;
          3. Treatment with immunosuppressive agents (including mycophenolate mofetil (Cellcept),&#xD;
             mycophenolate sodium (Myfortic), rituximab (Rituxan), tacrolimus (Prograf), sirolimus&#xD;
             (Rapamune), cyclosporine (Sandimmune), TNF-a inhibitors such as infliximab, etanercept&#xD;
             or adalimumab, methotrexate, azathioprine, and dactinomycin) within 4 weeks of consent&#xD;
             or planned initiation of any of these agents for 12 weeks after consent.&#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>Tian Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 11, 2022</last_update_submitted>
  <last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</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>Carcinoma</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</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/NCT02978118
org study id: Pro00076768
nct id: NCT02978118
lead sponsor: 
collaborator: 
has dmc: No
This pilot study purpose of this study is to describe peripheral circulating immune cell
      profiles at baseline and change on treatment with immune checkpoint inhibitors in renal cell
      carcinoma and urothelial carcinoma.
observational model: Cohort
time perspective: Prospective
measure: Change in the number of T-cells before and after treatment with immune therapies
time frame: Baseline and Disease progression (up to two years)
measure: Change in the number of B-cells before and after treatment with immune therapies
time frame: Baseline and Disease progression (up to two years)
measure: Change in the number of myeloid cells before and after treatment with immune therapies
time frame: Baseline and Disease progression (up to two years)
measure: Number of patients with detectable circulating tumor cells (CTCs)
time frame: Disease progression (up to two years)
measure: The prevalence of tumor-infiltrating lymphocytes for all subjects at baseline
time frame: Baseline
measure: The prevalence of tumor-associated macrophages for all subjects at baseline
time frame: Baseline
measure: The change in CTCs over time
time frame: Baseline, week 4, week 8, week 12 and progression (up to two years)
measure: The distribution of CTCs difference scores across the ordered tumor response categories of CR, PR, SD, and PD
time frame: Disease progression (up to two years)
measure: The change in tumor burden over time measured by RECIST
time frame: Baseline, Week 12, Progression (up to two years)
arm group label: Group A
description: Subjects in Group A (patients with metastatic renal cell carcinoma starting immune therapy) will have PBMC, plasma storage and analysis for immune cell profiles at baseline, 4 weeks, 12 weeks, and upon disease progression on treatment. Patients will have CTC assessment at baseline, 4 weeks, and upon disease progression. Urinary specimens will be collected at baseline, 4 weeks, 12 weeks, and disease progression. Fecal specimens will be collected at baseline (within 3 days of cycle 1 day 1), 4 weeks, and upon disease progression.
arm group label: Group B
description: Subjects in Group B (patients with metastatic urothelial carcinoma) will have PBMC and plasma storage and analysis for immune cell profiles at baseline, 4 weeks, 12 weeks, and upon disease progression on treatment. Patients will have CTC assessment at baseline, 4 weeks, and disease progression. Urinary specimens will be collected at baseline, 4 weeks, 12 weeks, and disease progression. Fecal specimens will be collected at baseline (within 3 days of cycle 1 day 1), 4 weeks, and upon disease progression.
intervention type: Device
intervention name: Immune cell and CTC detection procedures
description: Immune cell profiling assays (in blood and archival tumor samples) and circulating tumor cell assays (in blood samples)
arm group label: Group A
arm group label: Group B
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tian Zhang, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Neoplastic Cells, Circulating
mesh term: Carcinoma, Renal Cell