<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/NCT02186236</url>
  </required_header>
  <id_info>
    <org_study_id>14-114</org_study_id>
    <nct_id>NCT02186236</nct_id>
  </id_info>
  <brief_title>Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients</brief_title>
  <official_title>A Pilot Study Testing the Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardiff Oncology</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to see whether gene mutations can be found in the urine or blood&#xD;
      of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA&#xD;
      in a gene is damaged in a way that changes the genetic message carried by that gene. Gene&#xD;
      mutations can sometimes cause lung cancers. These gene mutations are only found in lung and&#xD;
      colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and&#xD;
      colorectal cancer tumors are now tested for different gene mutations as their presence&#xD;
      affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically&#xD;
      tested for these gene mutations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">September 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EGFR detection in urinary cell free DNA [cfDNA]</measure>
    <time_frame>2 years</time_frame>
    <description>The Trovagene urine-based assay will test to determine the presence of EGFR mutation in cfDNA or RAS/RAF mutation in colorectal cancer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To validate the Trovagene urine assay</measure>
    <time_frame>2 years</time_frame>
    <description>urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)</measure>
    <time_frame>2 years</time_frame>
    <description>The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Lung and Colorectal cancer patients</arm_group_label>
    <description>Eligible people who consent to participation will provide urine (both in lung cancer and colorectal cancer) and blood (in lung cancer only) samples at pre-specified times.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      periphera blood sample and urine sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        MSKCC clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Lung cancer:&#xD;
&#xD;
        For patients participating in Part A (initial testing) and Part B (serial testing):&#xD;
&#xD;
          -  Patients must have a diagnosis of stage IV lung adenocarcinoma undergoing systemic&#xD;
             therapy.&#xD;
&#xD;
          -  Patients must have had or intend to have EGFR mutation testing (specifically including&#xD;
             exon 19 deletions and L858R) performed on their tumor with results available from a&#xD;
             CLIA certified laboratory.&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
        Specific to patients participating in Part B (serial testing):&#xD;
&#xD;
          -  Patients must be planning to receive cancer care at Memorial-Sloan Kettering.&#xD;
&#xD;
          -  Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R)&#xD;
             with molecular testing results available from a CLIA certified laboratory.&#xD;
&#xD;
          -  Must be within 3 months of their diagnosis of metastatic lung cancer.&#xD;
&#xD;
          -  Treatment plan should include an EGFR tyrosine kinase inhibitor, but may concurrently&#xD;
             be on a therapeutic protocol.&#xD;
&#xD;
        Colorectal Cancer:&#xD;
&#xD;
        For patients participating in Part A (initial testing) and Part B (serial testing):&#xD;
&#xD;
          -  Patients must have a diagnosis of stage IV colorectal adenocarcinoma undergoing&#xD;
             systemic therapy or have recently progressed on therapy including anti-EGFR based&#xD;
             therapy.&#xD;
&#xD;
          -  Patients must have had or intend to have RAS/RAF mutation testing on their tumor with&#xD;
             results available from a CLIA certified laboratory. For the patients who recently&#xD;
             progressed on anti-EGFR must have tumor tissue molecular analyses preformed (prior to&#xD;
             enrolling or a plan to test it at the time of enrollment).&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
        Specific to patients participating in Part B (serial testing):&#xD;
&#xD;
          -  Patients must be planning to receive cancer care at Memorial-Sloan Kettering.&#xD;
&#xD;
          -  Patients must have a confirmed RAS/RAF mutant colorectal cancer with molecular testing&#xD;
             results available from a CLIA certified laboratory.&#xD;
&#xD;
          -  Must be within 3 months of their diagnosis of metastatic colorectal cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        lung cancer and colorectal cancer&#xD;
&#xD;
          -  Comorbidities that would prohibit or make serial urine collection difficult or&#xD;
             impossible&#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>Helena Yu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memoral Sloan Kettering Cancer Center</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center @ Suffolk</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering at Mercy Medical Center</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memoral Sloan Kettering Cancer Center at Phelps</name>
      <address>
        <city>Sleepy Hollow</city>
        <state>New York</state>
        <zip>10591</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering West Harrison</name>
      <address>
        <city>West Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>September 26, 2016</last_update_submitted>
  <last_update_submitted_qc>September 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Detection of Oncogenic Tumor Mutations</keyword>
  <keyword>blood</keyword>
  <keyword>urine</keyword>
  <keyword>14-114</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT02186236
org study id: 14-114
nct id: NCT02186236
lead sponsor: 
collaborator: 
The purpose of this study is to see whether gene mutations can be found in the urine or blood
      of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA
      in a gene is damaged in a way that changes the genetic message carried by that gene. Gene
      mutations can sometimes cause lung cancers. These gene mutations are only found in lung and
      colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and
      colorectal cancer tumors are now tested for different gene mutations as their presence
      affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically
      tested for these gene mutations.
observational model: Cohort
time perspective: Prospective
measure: EGFR detection in urinary cell free DNA [cfDNA]
time frame: 2 years
description: The Trovagene urine-based assay will test to determine the presence of EGFR mutation in cfDNA or RAS/RAF mutation in colorectal cancer
measure: To validate the Trovagene urine assay
time frame: 2 years
description: urine assay to identify EGFR mutations as compared to the gold standard of tumor tissue.
measure: EGFR detection in plasma circulating tumor cells [CTC] and plasma cfDNA)
time frame: 2 years
description: The plasma-based assay will test to determine the presence of EGFR mutation in CTC and in cfDNA.
arm group label: Lung and Colorectal cancer patients
description: Eligible people who consent to participation will provide urine (both in lung cancer and colorectal cancer) and blood (in lung cancer only) samples at pre-specified times.
periphera blood sample and urine sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Helena Yu, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Colorectal Neoplasms