<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/NCT03819569</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC 1834</org_study_id>
    <nct_id>NCT03819569</nct_id>
  </id_info>
  <brief_title>GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses</brief_title>
  <acronym>GRADE-SRM</acronym>
  <official_title>GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</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>
      Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on&#xD;
      decision-making for patients presenting with clinical T1 kidney tumors. This study also&#xD;
      incorporates integrated biomarker study to compare the genomic data obtained through biopsy&#xD;
      tissue to genomic information from surgical data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective&#xD;
&#xD;
        1. To compare the decisional conflict between patients who undergo renal mass biopsy during&#xD;
           their evaluation for SRMs versus those who do not.&#xD;
&#xD;
        2. To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk&#xD;
           stratification molecular biomarkers between renal biopsy tissue and surgical&#xD;
           (nephrectomy) specimen tissue.&#xD;
&#xD;
      Secondary objective&#xD;
&#xD;
      1. To characterize the impact of biopsy on patient reported anxiety and uncertainty,&#xD;
      assessment of cancer care communication, and satisfaction with cancer care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>non-randomized, comparative</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in decisional conflict score</measure>
    <time_frame>3 years</time_frame>
    <description>The validated 16-item Decisional conflict scale (0 to 100) will be measured before and after biopsy. Higher scores indicate more decisional conflict, scores below 25 indicate low decisional conflict</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The concordance of Molecular subtype generated from Clearcode 34 gene set on biopsy tissue compared to nephrectomy samples</measure>
    <time_frame>5 years</time_frame>
    <description>Molecular Subtype generated from ClearCode 34 gene set</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-reported anxiety</measure>
    <time_frame>3 years</time_frame>
    <description>The validated, 14-item hospital anxiety and depression scale (0-21). Higher scores indicate more depression and anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported assessment of communication in cancer care</measure>
    <time_frame>3 years</time_frame>
    <description>The validated, 6-item short-form for patient-centered communication-cancer scale. Each item is scored 1-5, and the overall score is an average of 6 questions, with 5 indicating the most satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported satisfaction with cancer care</measure>
    <time_frame>3 years</time_frame>
    <description>The 16-item validated Service Satisfaction Scale for Cancer Care (0-100). A higher score indicated higher satisfaction with cancer care.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Small Renal Mass</condition>
  <condition>Kidney Tumor</condition>
  <arm_group>
    <arm_group_label>Biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive a renal cell biopsy prior to making a decision about treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Biopsy</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects do not receive a renal cell biopsy prior to making a decision about treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Small Renal Mass Biopsy</intervention_name>
    <description>Subjects will receive a small renal mass biopsy prior to making a treatment decision</description>
    <arm_group_label>Biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Small Renal Mass Biopsy</intervention_name>
    <description>Subjects will not receive a small renal mass biopsy prior to making a treatment decision</description>
    <arm_group_label>No Biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18 - 95&#xD;
&#xD;
          -  Have a small renal mass ≤7 cm on cross-sectional radiologic study evaluated at the&#xD;
             University of North Carolina (UNC) Urology or the UNC Cancer Hospital.&#xD;
&#xD;
          -  Has voluntarily provided signed informed consent to participate and HIPAA&#xD;
             authorization for release of personal health information&#xD;
&#xD;
          -  Willing and able to complete patient-reported outcome questionnaires&#xD;
&#xD;
          -  Willing to have extra cores taken for research during standard of care biopsy&#xD;
             procedure&#xD;
&#xD;
          -  Willing to allow surgical specimens to be used for research&#xD;
&#xD;
          -  Willing to undergo a blood draw to evaluate for circulating tumor DNA&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Has staging information indicating locally advanced or metastatic disease.&#xD;
&#xD;
          -  Presence of transplant kidney&#xD;
&#xD;
          -  Unwilling or unable to complete informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hung J Tan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Lineberger Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>genomic risk assessment</keyword>
  <keyword>small renal mass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03819569
org study id: LCCC 1834
nct id: NCT03819569
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on
      decision-making for patients presenting with clinical T1 kidney tumors. This study also
      incorporates integrated biomarker study to compare the genomic data obtained through biopsy
      tissue to genomic information from surgical data.
Primary Objective

        1. To compare the decisional conflict between patients who undergo renal mass biopsy during
           their evaluation for SRMs versus those who do not.

        2. To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk
           stratification molecular biomarkers between renal biopsy tissue and surgical
           (nephrectomy) specimen tissue.

      Secondary objective

      1. To characterize the impact of biopsy on patient reported anxiety and uncertainty,
      assessment of cancer care communication, and satisfaction with cancer care.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: non-randomized, comparative
primary purpose: Other
masking: None (Open Label)
measure: Change in decisional conflict score
time frame: 3 years
description: The validated 16-item Decisional conflict scale (0 to 100) will be measured before and after biopsy. Higher scores indicate more decisional conflict, scores below 25 indicate low decisional conflict
measure: The concordance of Molecular subtype generated from Clearcode 34 gene set on biopsy tissue compared to nephrectomy samples
time frame: 5 years
description: Molecular Subtype generated from ClearCode 34 gene set
measure: Patient-reported anxiety
time frame: 3 years
description: The validated, 14-item hospital anxiety and depression scale (0-21). Higher scores indicate more depression and anxiety
measure: Patient-reported assessment of communication in cancer care
time frame: 3 years
description: The validated, 6-item short-form for patient-centered communication-cancer scale. Each item is scored 1-5, and the overall score is an average of 6 questions, with 5 indicating the most satisfaction
measure: Patient-reported satisfaction with cancer care
time frame: 3 years
description: The 16-item validated Service Satisfaction Scale for Cancer Care (0-100). A higher score indicated higher satisfaction with cancer care.
arm group label: Biopsy
arm group type: Active Comparator
description: Subjects receive a renal cell biopsy prior to making a decision about treatment
arm group label: No Biopsy
arm group type: Sham Comparator
description: Subjects do not receive a renal cell biopsy prior to making a decision about treatment
intervention type: Procedure
intervention name: Small Renal Mass Biopsy
description: Subjects will receive a small renal mass biopsy prior to making a treatment decision
arm group label: Biopsy
intervention type: Other
intervention name: No Small Renal Mass Biopsy
description: Subjects will not receive a small renal mass biopsy prior to making a treatment decision
arm group label: No Biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Hung J Tan, MD
role: Principal Investigator
affiliation: UNC Lineberger Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Neoplasms
sharing ipd: No