<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/NCT04415697</url>
  </required_header>
  <id_info>
    <org_study_id>BarretosCH-20201</org_study_id>
    <nct_id>NCT04415697</nct_id>
  </id_info>
  <brief_title>Identification of Predictive Gene Expression Profile of Sunitinib Response in Metastatic Clear Cell Renal Carcinomas</brief_title>
  <official_title>Identification of Predictive Gene Expression Profile of Sunitinib Rate Response in Metastatic Clear Cell Renal Carcinomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barretos Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barretos Cancer Hospital</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>
      Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney&#xD;
      cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies&#xD;
      have emerged in recent years for the treatment of metastatic kidney cancer. Due to the&#xD;
      heterogeneity of these patients and the lack of specific markers, therapeutic is currently&#xD;
      based on clinical and laboratory analysis. The research for predictive biomarkers may better&#xD;
      characterize the kidney cancer therapeutic management. The objectives are to identify a&#xD;
      predictive gene expression profile in patients with advanced clear cell renal carcinoma&#xD;
      treated with first-line sunitinib and correlate it with rate response, seeking to identify a&#xD;
      predictive gene expression profile. As secondary objectives, the investigators will compare&#xD;
      the gene expression profile found, with global survival and clinical-pathological&#xD;
      characteristics. Materials and methods: To determine through systematic data collection the&#xD;
      epidemiological profile, clinical-pathological characteristics, response rate, disease free&#xD;
      survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who&#xD;
      used sunitinib in the first line between 2009 and 2018 at the Barretos Cancer Hospital. For&#xD;
      evaluation of gene expression profile, the investigators will use a panel of a panel with 770&#xD;
      genes related to disease progression using nanostring technology.&#xD;
&#xD;
      Keywords: Renal Cell Carcinoma; Sunitinib; Biomarkers; Gene expression; Nanostring.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">April 10, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify differentially expressed genes in two groups of objective response rate.</measure>
    <time_frame>One year</time_frame>
    <description>Identify differentially expressed genes, through the nanoString platform, in two groups of objective response rate defined using the RECIST 1.1 criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.</measure>
    <time_frame>One Year</time_frame>
    <description>Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital and correlate with data from differentially expressed genes.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Kidney Cancer</condition>
  <condition>Biomarkers</condition>
  <condition>Gene Expression</condition>
  <arm_group>
    <arm_group_label>Responders</arm_group_label>
    <description>Those who present complete response, partial response, or stable disease, according to RECIST 1.1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not responders</arm_group_label>
    <description>Those who present progression disease according to RECIST 1.1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Gene expression test using nanostring technology.</intervention_name>
    <description>Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology</description>
    <arm_group_label>Not responders</arm_group_label>
    <arm_group_label>Responders</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The samples retained in a biobank, with potential for RNA extraction, as genetic material was&#xD;
      extracted and stored at - 80 degrees celsius, in the form of a just frozen sample/tissue.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults patients at least 18 years with diagnosis of metastatic clear cell renal carcinoma&#xD;
        treated with sunitinib in Barretos Cancer Hospital between Jan/2009 and Jan/2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  At least 18 years&#xD;
&#xD;
          -  Metastatic clear cell renal carcinoma&#xD;
&#xD;
          -  Primary tumors sample of nephrectomy or core biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insufficient sample for molecular analysis&#xD;
&#xD;
          -  Patients with no record of treatment response data&#xD;
&#xD;
          -  Patients with a history of previous systemic treatment for Metastatic clear cell renal&#xD;
             carcinoma&#xD;
&#xD;
          -  Patients with second primary synchronic or metachronic tumor undergoing treatment&#xD;
&#xD;
          -  Patients having received less than one cycle of sunitinib in the first line&#xD;
&#xD;
          -  Patients have received previous adjuvant and/or neoadjuvant treatment with an interval&#xD;
             &lt; 1 year between the end of treatment and the diagnosis of metastasis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Andre Octavio Nicolau Sanches</name>
      <address>
        <city>Barretos</city>
        <state>Sao Paulo</state>
        <zip>14784400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barretos Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Andre Octavio Nicolau Sanches</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Kidney Cancer</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Gene expression</keyword>
  <keyword>Predictive rate response</keyword>
  <keyword>Nanostring</keyword>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04415697
org study id: BarretosCH-20201
nct id: NCT04415697
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Renal cell carcinoma accounts for 2-3% of all cancers in western countries. Brazilian kidney
      cancer data show an incidence of 6,270 new cases for 2018. New target-molecular therapies
      have emerged in recent years for the treatment of metastatic kidney cancer. Due to the
      heterogeneity of these patients and the lack of specific markers, therapeutic is currently
      based on clinical and laboratory analysis. The research for predictive biomarkers may better
      characterize the kidney cancer therapeutic management. The objectives are to identify a
      predictive gene expression profile in patients with advanced clear cell renal carcinoma
      treated with first-line sunitinib and correlate it with rate response, seeking to identify a
      predictive gene expression profile. As secondary objectives, the investigators will compare
      the gene expression profile found, with global survival and clinical-pathological
      characteristics. Materials and methods: To determine through systematic data collection the
      epidemiological profile, clinical-pathological characteristics, response rate, disease free
      survival and overall survival of 60 patients with metastatic clear cell renal carcinoma who
      used sunitinib in the first line between 2009 and 2018 at the Barretos Cancer Hospital. For
      evaluation of gene expression profile, the investigators will use a panel of a panel with 770
      genes related to disease progression using nanostring technology.

      Keywords: Renal Cell Carcinoma; Sunitinib; Biomarkers; Gene expression; Nanostring.
observational model: Cohort
time perspective: Retrospective
measure: Identify differentially expressed genes in two groups of objective response rate.
time frame: One year
description: Identify differentially expressed genes, through the nanoString platform, in two groups of objective response rate defined using the RECIST 1.1 criteria.
measure: Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital.
time frame: One Year
description: Epidemiological characterization of the metastatic clear cell renal carcinoma population treated with sunitinib in the first line, from Barretos Cancer Hospital and correlate with data from differentially expressed genes.
arm group label: Responders
description: Those who present complete response, partial response, or stable disease, according to RECIST 1.1.
arm group label: Not responders
description: Those who present progression disease according to RECIST 1.1.
intervention type: Diagnostic Test
intervention name: Gene expression test using nanostring technology.
description: Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology
arm group label: Not responders
arm group label: Responders
The samples retained in a biobank, with potential for RNA extraction, as genetic material was
      extracted and stored at - 80 degrees celsius, in the form of a just frozen sample/tissue.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Barretos Cancer Hospital
investigator full name: Andre Octavio Nicolau Sanches
investigator title: Medical Doctor
mesh term: Kidney Neoplasms
mesh term: Carcinoma, Renal Cell
sharing ipd: Undecided