<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/NCT04472663</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-7DK</org_study_id>
    <nct_id>NCT04472663</nct_id>
  </id_info>
  <brief_title>Participant Reported Outcomes and Treatment Experiences in Kidney Cancer</brief_title>
  <official_title>Patient Reported Outcomes And Treatment Experiences In Renal Cell Carcinoma (ONE-RCC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to collect contemporary real-world treatment&#xD;
      patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific&#xD;
      Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or&#xD;
      adverse reactions (ARs) among Advanced Renal Cell Carcinoma (aRCC) patients initiating&#xD;
      first-line systemic therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Actual">December 9, 2020</completion_date>
  <primary_completion_date type="Actual">December 9, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 36 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease-related symptoms as measured by change from baseline in FKSI-DRS</measure>
    <time_frame>Up to 36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of aRCC patients as measured by continuous statistics: Age</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of aRCC patients as measured by categorical statistics: Gender</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of aRCC patients as measured by continuous statistics: Height</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequence of therapy events including treatment modalities</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to therapy initiation of LOT</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rationale for therapy selection</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Switching and/or discontinuation rate</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use characteristics including dosing regimens: Drugs included in each course of therapy</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use characteristics including dosing regimens : Formulations</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use characteristics including dosing regimens : Dose</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use characteristics including dosing regimens : Frequency of administration</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use characteristics including dosing regimens: Duration of therapy</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug use characteristics including dosing regimens : Number of cycles planned and administered</measure>
    <time_frame>Up to 36 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>Kidney Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Retrospective Long-term Chart Review</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>Prospective-Retrospective Chart Review and Humanistic Burden</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be included if they have primary diagnosis of aRCC, age ≥18 years, with&#xD;
        medical history available from date of aRCC diagnosis to most recent or current therapy.&#xD;
        For Cohort 1, patients will be eligible if they had initiated 1LOT between April 2018 -&#xD;
        March 2020. For Cohort 2, patients will be eligible if they are about to initiate 1LOT,&#xD;
        must be willing to sign the informed consent form (ICF), where required, and complete the&#xD;
        humanistic burden assessment at baseline and subsequent follow-ups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Cohort 1&#xD;
&#xD;
          -  Primary diagnosis of aRCC (advanced Renal Cell Carcinoma) or metastatic RCC&#xD;
&#xD;
          -  Medical history must be available from date of aRCC diagnosis&#xD;
&#xD;
          -  Initiated 1LOT between April 2018 - March 2020&#xD;
&#xD;
        Cohort 2:&#xD;
&#xD;
          -  Primary diagnosis of aRCC (not amenable to curative surgery or radiation therapy/ AJCC&#xD;
             Stage III unresectable) or metastatic RCC (AJCC Stage IV).&#xD;
&#xD;
          -  Medical history must be available from date of aRCC diagnosis.&#xD;
&#xD;
          -  Initiate 1LOT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in a clinical trial for treatment of aRCC&#xD;
&#xD;
          -  Any prior malignancy active within the previous 3 year, except for locally curable&#xD;
             cancers that have been cured&#xD;
&#xD;
          -  Any prior systemic therapy for aRCC, with the exception of neoadjuvant or adjuvant&#xD;
             therapy (Cohort 2 only)&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 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>Kidney Neoplasms</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/NCT04472663
org study id: CA209-7DK
nct id: NCT04472663
lead sponsor: 
has dmc: No
The purpose of this observational study is to collect contemporary real-world treatment
      patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific
      Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or
      adverse reactions (ARs) among Advanced Renal Cell Carcinoma (aRCC) patients initiating
      first-line systemic therapy.
observational model: Cohort
time perspective: Other
measure: Overall Survival (OS)
time frame: Up to 36 months
measure: Disease-related symptoms as measured by change from baseline in FKSI-DRS
time frame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Age
time frame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by categorical statistics: Gender
time frame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity
time frame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Height
time frame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status
time frame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC
time frame: Up to 36 months
measure: Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)
time frame: Up to 36 months
measure: Sequence of therapy events including treatment modalities
time frame: Up to 36 months
measure: Time to therapy initiation of LOT
time frame: Up to 36 months
measure: Rationale for therapy selection
time frame: Up to 36 months
measure: Switching and/or discontinuation rate
time frame: Up to 36 months
measure: Drug use characteristics including dosing regimens: Drugs included in each course of therapy
time frame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Formulations
time frame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Dose
time frame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Frequency of administration
time frame: Up to 36 months
measure: Drug use characteristics including dosing regimens: Duration of therapy
time frame: Up to 36 months
measure: Drug use characteristics including dosing regimens : Number of cycles planned and administered
time frame: Up to 36 months
arm group label: Cohort 1
description: Retrospective Long-term Chart Review
arm group label: Cohort 2
description: Prospective-Retrospective Chart Review and Humanistic Burden
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Kidney Neoplasms
mesh term: Carcinoma, Renal Cell