<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/NCT03748901</url>
  </required_header>
  <id_info>
    <org_study_id>CMA-Ate004</org_study_id>
    <nct_id>NCT03748901</nct_id>
  </id_info>
  <brief_title>PD-L1 Expression in Japanese Renal Cell Carcinoma Patients</brief_title>
  <official_title>A Retrospective Multicenter Analysis of PD-L1 Expression in Japanese Renal Cell Carcinoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chugai Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chugai Pharmaceutical</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 multicenter retrospective study designed to compare overall survival (OS) by PD-L1&#xD;
      expression status in patients with RCC who have received systemic chemotherapy for recurrent&#xD;
      or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in&#xD;
      PD-L1-negative RCC.&#xD;
&#xD;
      Total 600 RCC surgical specimens will be collected from patients who started systemic&#xD;
      chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at&#xD;
      about 30 participating study sites in Japan.&#xD;
&#xD;
      PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be&#xD;
      evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3&#xD;
      (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed&#xD;
      between IC0 and IC1/2/3.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2018</start_date>
  <completion_date type="Actual">July 21, 2021</completion_date>
  <primary_completion_date type="Actual">July 21, 2021</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>Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients.</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3)</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival after nephrectomy (including cytoreductive nephrectomy)</measure>
    <time_frame>Baseline</time_frame>
    <description>Overall survival is defined the time from nephrectomy (including cytoreductive nephrectomy) to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence after radical nephrectomy</measure>
    <time_frame>Baseline</time_frame>
    <description>Time to recurrence after radical nephrectomy is the duration from the day of surgery to diagnosis of recurrent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment duration (first-line and second-line therapy)</measure>
    <time_frame>Baseline</time_frame>
    <description>Treatment duration is the duration from the day1 of systemic therapy for mRCC to the end of the treatment.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">830</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Full analysis set</arm_group_label>
    <description>Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with recurrent or metastatic RCC who have initiated first line treatment between 1&#xD;
        January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical&#xD;
        specimen which are suitable for assessment of PD-L1 expression&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Written informed consent for this study. In the case obtaining written informed&#xD;
             consent is difficult due to death, change of address, and so on, the opt-out consent&#xD;
             is accepted by giving patients or their relatives notification regarding the usage of&#xD;
             their clinical information and surgical samples for the research.&#xD;
&#xD;
          -  2. Age at nephrectomy≧20 years&#xD;
&#xD;
          -  3.Patients with recurrent or metastatic RCC who have initiated first line treatment&#xD;
             between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy&#xD;
             surgical specimen which are suitable for assessment of PD-L1 expression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Malignancies other than RCC is co-existed from the time of nephrectomy and death.&#xD;
&#xD;
          -  2. Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line&#xD;
             therapy for recurrent or metastatic RCC.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aichi Medical University</name>
      <address>
        <city>Nagoya-city</city>
        <state>Aichi</state>
        <zip>480-1103</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (ClinicalStudyDataRequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html)</ipd_description>
  </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/NCT03748901
org study id: CMA-Ate004
nct id: NCT03748901
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1
      expression status in patients with RCC who have received systemic chemotherapy for recurrent
      or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in
      PD-L1-negative RCC.

      Total 600 RCC surgical specimens will be collected from patients who started systemic
      chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at
      about 30 participating study sites in Japan.

      PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be
      evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3
      (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed
      between IC0 and IC1/2/3.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients.
time frame: Baseline
description: Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.
measure: Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3)
time frame: Baseline
description: Overall survival is defined as the time from the initiation date of first line treatment to death due to any cause.
measure: Overall survival after nephrectomy (including cytoreductive nephrectomy)
time frame: Baseline
description: Overall survival is defined the time from nephrectomy (including cytoreductive nephrectomy) to death due to any cause.
measure: Time to recurrence after radical nephrectomy
time frame: Baseline
description: Time to recurrence after radical nephrectomy is the duration from the day of surgery to diagnosis of recurrent.
measure: Treatment duration (first-line and second-line therapy)
time frame: Baseline
description: Treatment duration is the duration from the day1 of systemic therapy for mRCC to the end of the treatment.
arm group label: Full analysis set
description: Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (ClinicalStudyDataRequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html)