<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/NCT03291028</url>
  </required_header>
  <id_info>
    <org_study_id>GU-118</org_study_id>
    <nct_id>NCT03291028</nct_id>
  </id_info>
  <brief_title>Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma</brief_title>
  <official_title>Defining the Genomic and Histologic Landscape of Primary and Metastatic Tumors With Divergent Kinetics in Patients With Renal Cell Carcinoma (RCC) and Urothelial Carcinoma (UC) Treated With Immune Checkpoint Blockade (ICB)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fox Chase Cancer Center</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>
      This is a comparative study using resected/ biopsied tumors samples collected from renal cell&#xD;
      carcinoma and urothelial carcinoma patients who underwent surgical removal of lesions,&#xD;
      followed by immune checkpoint blockade (ICB) treatment targting programmed cell death 1 (PD1)&#xD;
      but developed new lesions later were also removed and stored in the biosample repository&#xD;
      (BSR). The histology and genomic analysis of the pre-treatment and metastatic samples from&#xD;
      the same patient would be used to find out the changes that may have lead to metastasis.&#xD;
      Also, metastatic samples from ICB naive patients would be collected and compared with those&#xD;
      from ICB treated patients to find out if the metastasis in treated patients was due to&#xD;
      development of reistance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Histopathological characterization of samples from ICB treated patients</measure>
    <time_frame>18 months</time_frame>
    <description>To characterize differences in histopathology and patterns of genomic expression between baseline tumors and metastases exhibiting divergent growth kinetics (&quot;escape&quot; metastases) in patients treated with immune checkpoint blockade (ICB)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Genomic characterization of samples from ICB treated patients</measure>
    <time_frame>18 months</time_frame>
    <description>To characterize expression of different genes between baseline tumors and metastases exhibiting divergent growth kinetics (&quot;escape&quot; metastases) in patients treated with immune checkpoint blockade (ICB)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histopathological characterization of samples from patients treated with targeted or observational therapy</measure>
    <time_frame>18 months</time_frame>
    <description>To characterize differences in histopathology between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients</measure>
    <time_frame>18 months</time_frame>
    <description>To characterize differences in histopathology and patterns of genomic expression between &quot;escape&quot; metastases in patients treated with ICB from patients treated with targeted therapy or observation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genomic characterization of samples from patients treated with targeted or observational therapy</measure>
    <time_frame>18 months</time_frame>
    <description>To characterize differences in patterns of genomic expression between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients</measure>
    <time_frame>18 months</time_frame>
    <description>To characterize differences in patterns of genomic expression between &quot;escape&quot; metastases in patients treated with ICB from patients treated with targeted therapy or observation.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Bladder Cancer</condition>
  <condition>Ureter Cancer</condition>
  <condition>Urethral Cancer</condition>
  <arm_group>
    <arm_group_label>Patients treated with immune check point blocker</arm_group_label>
    <description>Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients treated with targeted/ observational therapy</arm_group_label>
    <description>Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Immune checkpoint inhibitor targeting PD1</intervention_name>
    <description>RCC and UC patients treated with immune checkpoint blockade</description>
    <arm_group_label>Patients treated with immune check point blocker</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsied/ resected tumor samples that have been stored in the biosample repository would be&#xD;
      used for the study&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        RCC and UC patients who were treated with ICB but developed metastatis post-treatment that&#xD;
        was resected&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients will include retrospectively identified patients with RCC or UC who&#xD;
             have received treatment with ICB and achieved clinical benefit but subsequently&#xD;
             developed a solitary new/progressive lesion that was removed surgically. Patients with&#xD;
             other tumor types who otherwise meet criteria may be included at a later time&#xD;
&#xD;
          -  Additionally, a group of patients with RCC who have undergone a metastasectomy but who&#xD;
             did not receive treatment with ICB will be identified. These patients may be&#xD;
             approached for study participation to serve as a comparator group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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_contact>
    <last_name>Matthew Zibelman, MD</last_name>
    <phone>215 214 1515</phone>
    <email>matthew.zibelman@fccc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fox Chase Cancer Center - Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111-2497</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Plimack, MD</last_name>
      <phone>215-728-4790</phone>
      <email>Elizabeth.Plimack@fccc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</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>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
    <mesh_term>Urethral Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Ureteral Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immune Checkpoint Inhibitors</mesh_term>
  </intervention_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/NCT03291028
org study id: GU-118
nct id: NCT03291028
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a comparative study using resected/ biopsied tumors samples collected from renal cell
      carcinoma and urothelial carcinoma patients who underwent surgical removal of lesions,
      followed by immune checkpoint blockade (ICB) treatment targting programmed cell death 1 (PD1)
      but developed new lesions later were also removed and stored in the biosample repository
      (BSR). The histology and genomic analysis of the pre-treatment and metastatic samples from
      the same patient would be used to find out the changes that may have lead to metastasis.
      Also, metastatic samples from ICB naive patients would be collected and compared with those
      from ICB treated patients to find out if the metastasis in treated patients was due to
      development of reistance.
observational model: Cohort
time perspective: Retrospective
measure: Histopathological characterization of samples from ICB treated patients
time frame: 18 months
description: To characterize differences in histopathology and patterns of genomic expression between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)
measure: Genomic characterization of samples from ICB treated patients
time frame: 18 months
description: To characterize expression of different genes between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)
measure: Histopathological characterization of samples from patients treated with targeted or observational therapy
time frame: 18 months
description: To characterize differences in histopathology between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy.
measure: Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients
time frame: 18 months
description: To characterize differences in histopathology and patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.
measure: Genomic characterization of samples from patients treated with targeted or observational therapy
time frame: 18 months
description: To characterize differences in patterns of genomic expression between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy
measure: Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients
time frame: 18 months
description: To characterize differences in patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.
arm group label: Patients treated with immune check point blocker
description: Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later
arm group label: Patients treated with targeted/ observational therapy
description: Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy
intervention type: Biological
intervention name: Immune checkpoint inhibitor targeting PD1
description: RCC and UC patients treated with immune checkpoint blockade
arm group label: Patients treated with immune check point blocker
Biopsied/ resected tumor samples that have been stored in the biosample repository would be
      used for the study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Matthew Zibelman, MD
phone: 215 214 1515
email: matthew.zibelman@fccc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Carcinoma, Transitional Cell
mesh term: Urethral Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Ureteral Neoplasms
mesh term: Immune Checkpoint Inhibitors