<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/NCT02204800</url>
  </required_header>
  <id_info>
    <org_study_id>1312013110</org_study_id>
    <secondary_id>Yale Department of Urology</secondary_id>
    <nct_id>NCT02204800</nct_id>
  </id_info>
  <brief_title>Active Surveillance of the Small Renal Mass</brief_title>
  <official_title>Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Active surveillance in kidney cancer involves closely observing the tumor with periodic&#xD;
      imaging studies rather than immediately proceeding to an invasive treatment. This does not&#xD;
      mean that the tumor is ignored or that future treatment is not necessary, rather it means the&#xD;
      tumor does not require treatment at this time. On active surveillance, a tumor is closely&#xD;
      monitored without treatment, however if the tumor changes and reaches a predefined threshold&#xD;
      that your physician no longer considers safe, your physician will strongly encourage&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While some patients with small kidney tumors may require eventual treatment, most do not.&#xD;
      Therefore, the American Urologic Association considers active surveillance an acceptable&#xD;
      treatment strategy. This protocol is a prospective study of active surveillance for small&#xD;
      clear cell kidney tumors (the most common type of kidney tumor) and is designed to identify&#xD;
      if there are predictive markers that may help identify which patients are unlikely to require&#xD;
      surgical treatment. Predictive markers are measurable characteristics that may predict the&#xD;
      future behavior of a tumor. There are currently no available predictive markers that can help&#xD;
      identify which tumors are not destined to require treatment. Such a marker may be useful to&#xD;
      increase the use of active surveillance by informing patients with small renal tumors that&#xD;
      immediate treatment may be considered overtreatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor growth rate</measure>
    <time_frame>36 months</time_frame>
    <description>Tumor growth rate is being measured in centimeters/year</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Small Renal Mass, Kidney Cancer</condition>
  <arm_group>
    <arm_group_label>Small clear cell renal tumors (Wild Type)</arm_group_label>
    <description>No specific chromatin remodeling gene (CRG) alteration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Small clear cell renal tumors (Mutant)</arm_group_label>
    <description>Specific chromatin remodeling gene (CRG) alteration</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This is a trial of active surveillance in patients with a solitary, small (1.0-2.7 cm)&#xD;
        renal mass.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Life expectancy &gt;3 years (by physician estimate)&#xD;
&#xD;
          -  Measurable, solid renal neoplasm, 1.0 -2.7 cm in size and visible on ultrasound&#xD;
&#xD;
          -  Clear cell renal cell carcinoma histology&#xD;
&#xD;
          -  Renal tumor diagnosed within 6 months&#xD;
&#xD;
          -  Recent biopsy (&lt;6 weeks) performed, if performed at an outside institution, there must&#xD;
             be sufficient material for biomarker analysis&#xD;
&#xD;
          -  No evidence of vascular invasion or regional nodal/distant disease&#xD;
&#xD;
          -  Renal tumor that is able to be managed with upfront surgery&#xD;
&#xD;
          -  Adequate organ function (Hemoglobin &gt; 9, Absolute neutrophil count (ANC) ≥ 1500/μL&#xD;
             Platelets ≥ 100,000/μL, AST and ALT ≤3.0 upper limit of normal (ULN), total bilirubin&#xD;
             ≤ ULN, eGFR ≥ 30&#xD;
&#xD;
          -  Good Performance status (ECOG ≤2)&#xD;
&#xD;
          -  Understanding and willingness to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of a hereditary renal cancer syndrome&#xD;
&#xD;
          -  Tumor &gt;2.7 cm, stages T1b-T4&#xD;
&#xD;
          -  Life expectancy &lt;3 years&#xD;
&#xD;
          -  Presence of an active, untreated, metastatic non-renal malignancy&#xD;
&#xD;
          -  Uncontrolled medical illness including infections, hypertension, arrhythmias, heart&#xD;
             failure, or myocardial infarction within 6 months that would predispose to immediate&#xD;
             surgical therapy&#xD;
&#xD;
          -  Medical contraindication to upfront surgical management of renal mass&#xD;
&#xD;
          -  History of bleeding diathesis or recent bleeding episode that would prevent surgical&#xD;
             resection&#xD;
&#xD;
          -  Unwillingness to undergo monitoring and imaging studies&#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>Brian Shuch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale New Haven Hospital Smilow Cancer Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tumor growth rate in maximal dimension, biomarker assessment based on driver gene alterations (specifically CRG)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</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/NCT02204800
org study id: 1312013110
secondary id: Yale Department of Urology
nct id: NCT02204800
lead sponsor: 
has dmc: No
Active surveillance in kidney cancer involves closely observing the tumor with periodic
      imaging studies rather than immediately proceeding to an invasive treatment. This does not
      mean that the tumor is ignored or that future treatment is not necessary, rather it means the
      tumor does not require treatment at this time. On active surveillance, a tumor is closely
      monitored without treatment, however if the tumor changes and reaches a predefined threshold
      that your physician no longer considers safe, your physician will strongly encourage
      treatment.
While some patients with small kidney tumors may require eventual treatment, most do not.
      Therefore, the American Urologic Association considers active surveillance an acceptable
      treatment strategy. This protocol is a prospective study of active surveillance for small
      clear cell kidney tumors (the most common type of kidney tumor) and is designed to identify
      if there are predictive markers that may help identify which patients are unlikely to require
      surgical treatment. Predictive markers are measurable characteristics that may predict the
      future behavior of a tumor. There are currently no available predictive markers that can help
      identify which tumors are not destined to require treatment. Such a marker may be useful to
      increase the use of active surveillance by informing patients with small renal tumors that
      immediate treatment may be considered overtreatment.
observational model: Other
time perspective: Prospective
measure: Tumor growth rate
time frame: 36 months
description: Tumor growth rate is being measured in centimeters/year
arm group label: Small clear cell renal tumors (Wild Type)
description: No specific chromatin remodeling gene (CRG) alteration
arm group label: Small clear cell renal tumors (Mutant)
description: Specific chromatin remodeling gene (CRG) alteration
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Shuch, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Neoplasms