<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/NCT01734915</url>
  </required_header>
  <id_info>
    <org_study_id>12-353</org_study_id>
    <nct_id>NCT01734915</nct_id>
  </id_info>
  <brief_title>Detecting EGFR T790M Mutations From Circulating Tumor Cells</brief_title>
  <official_title>Detecting EGFR T790M Mutations From Circulating Tumor Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine if the EGFR mutation can be detected in&#xD;
      CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the&#xD;
      bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of&#xD;
      patients with cancer. This is an experimental device. Using this device, the investigators&#xD;
      will test participants' blood to try and find CTCs with the EGFR mutation and compare them&#xD;
      with the results from the biopsy your doctor has recommended. The long-term goal of this&#xD;
      research is to develop a way to test for the EGFR mutation that is less invasive than a tumor&#xD;
      biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to participate in this study you need to have a diagnosis of NSCLC that has spread&#xD;
      or is unable to be surgically removed. In addition, your cancer must have an EGFR mutation&#xD;
      and you must have a scheduled (or recently performed) biopsy to check on the presence of any&#xD;
      other mutations related to targeted drug resistance.&#xD;
&#xD;
      After you sign consent to participate in this study we will draw a blood sample (three tubes&#xD;
      of blood). This is about 6 teaspoons of blood.&#xD;
&#xD;
      The number of CTCs in your blood will not be reported to you since it is not known if this&#xD;
      number has any meaning or if it impacts your medical care in any way. These results will not&#xD;
      become part of your medical record. They will be kept in a separate, secure location.&#xD;
&#xD;
      We will collect information from your medical records and store it in a research record that&#xD;
      we create about you. The study team will use this information to compare details about your&#xD;
      medical history with the results of the experiments done on your blood.&#xD;
&#xD;
      Genetic material (DNA) will be removed from the CTCs found in your blood. This genetic&#xD;
      material will be stored at the Massachusetts General Hospital and studied along with samples&#xD;
      from other participants on this research study. Your samples will not be labeled with your&#xD;
      name or any information that identifies you. Your samples will have a study-specific code&#xD;
      number on them. The code linking your name to the sample will be kept in a secure location,&#xD;
      available only to the investigators of the study and select study team members.&#xD;
&#xD;
      After the blood draw we will follow your status every 6 months by reviewing your medical&#xD;
      records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2016</completion_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>Number of patients with detectable EGFR mutations in their CTCs</measure>
    <time_frame>2 years</time_frame>
    <description>Calculate the number of patients in the study population with detectable EGFR mutations in the CTCs in order to demonstrate the feasibility of testing for EGFR mutations from captured CTCs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with CTC-derived EGFR genotyping matching their tumor-derived EGFR genotyping</measure>
    <time_frame>2 yearss</time_frame>
    <description>Determine the concordance of EGFR genotyping from CTCs compared to tumor tissue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with EGFR gentoype results detectable from plasma cfDNA</measure>
    <time_frame>2 years</time_frame>
    <description>Explore the feasibility of EGFR genotyping from plasma circulating free DNA (cfDNA)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>NSCLC</arm_group_label>
    <description>Subjects with advanced NSCLC, will undergo blood draw</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Circulating tumor cell chip</intervention_name>
    <description>three tubes (6 teaspoons) of peripheral blood are drawn and are analyzed using the CTC chip</description>
    <arm_group_label>NSCLC</arm_group_label>
    <other_name>Herringbone circulating tumor cell chip, herringbone CTC chip, HBCTC chip</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Circulating Tumor Cells (CTCs)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Receiving treatment for NSCLC at one of the participating cancer centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed NSCLC that is metastatic or unresectable&#xD;
&#xD;
          -  Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</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>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>September 23, 2016</last_update_submitted>
  <last_update_submitted_qc>September 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Lecia V. Sequist</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Advanced</keyword>
  <keyword>EGFR mutation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplastic Cells, Circulating</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iproplatin</mesh_term>
  </intervention_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/NCT01734915
org study id: 12-353
nct id: NCT01734915
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this research study is to determine if the EGFR mutation can be detected in
      CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the
      bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of
      patients with cancer. This is an experimental device. Using this device, the investigators
      will test participants' blood to try and find CTCs with the EGFR mutation and compare them
      with the results from the biopsy your doctor has recommended. The long-term goal of this
      research is to develop a way to test for the EGFR mutation that is less invasive than a tumor
      biopsy.
In order to participate in this study you need to have a diagnosis of NSCLC that has spread
      or is unable to be surgically removed. In addition, your cancer must have an EGFR mutation
      and you must have a scheduled (or recently performed) biopsy to check on the presence of any
      other mutations related to targeted drug resistance.

      After you sign consent to participate in this study we will draw a blood sample (three tubes
      of blood). This is about 6 teaspoons of blood.

      The number of CTCs in your blood will not be reported to you since it is not known if this
      number has any meaning or if it impacts your medical care in any way. These results will not
      become part of your medical record. They will be kept in a separate, secure location.

      We will collect information from your medical records and store it in a research record that
      we create about you. The study team will use this information to compare details about your
      medical history with the results of the experiments done on your blood.

      Genetic material (DNA) will be removed from the CTCs found in your blood. This genetic
      material will be stored at the Massachusetts General Hospital and studied along with samples
      from other participants on this research study. Your samples will not be labeled with your
      name or any information that identifies you. Your samples will have a study-specific code
      number on them. The code linking your name to the sample will be kept in a secure location,
      available only to the investigators of the study and select study team members.

      After the blood draw we will follow your status every 6 months by reviewing your medical
      records.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with detectable EGFR mutations in their CTCs
time frame: 2 years
description: Calculate the number of patients in the study population with detectable EGFR mutations in the CTCs in order to demonstrate the feasibility of testing for EGFR mutations from captured CTCs
measure: Number of patients with CTC-derived EGFR genotyping matching their tumor-derived EGFR genotyping
time frame: 2 yearss
description: Determine the concordance of EGFR genotyping from CTCs compared to tumor tissue
measure: Number of patients with EGFR gentoype results detectable from plasma cfDNA
time frame: 2 years
description: Explore the feasibility of EGFR genotyping from plasma circulating free DNA (cfDNA)
arm group label: NSCLC
description: Subjects with advanced NSCLC, will undergo blood draw
intervention type: Device
intervention name: Circulating tumor cell chip
description: three tubes (6 teaspoons) of peripheral blood are drawn and are analyzed using the CTC chip
arm group label: NSCLC
other name: Herringbone circulating tumor cell chip, herringbone CTC chip, HBCTC chip
Circulating Tumor Cells (CTCs)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Lecia V. Sequist
investigator title: Principal Investigator
mesh term: Neoplastic Cells, Circulating
mesh term: Iproplatin