<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/NCT03236675</url>
  </required_header>
  <id_info>
    <org_study_id>ECT2015-003A</org_study_id>
    <nct_id>NCT03236675</nct_id>
  </id_info>
  <brief_title>Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients</brief_title>
  <official_title>Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exosome Diagnostics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Exosome Diagnostics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation&#xD;
      from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK&#xD;
      fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis,&#xD;
      using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M&#xD;
      EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis,&#xD;
      using an institutionally accepted assay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Anticipated">February 2022</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>ALK mutation by tissue assay.</measure>
    <time_frame>Two years</time_frame>
    <description>Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T790M EGFR mutation by tissue assay</measure>
    <time_frame>Two years</time_frame>
    <description>Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>EML4-ALK</arm_group_label>
    <description>ALK positive patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>T790M EGFR</arm_group_label>
    <description>T790M positive patients</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      10-20 mL of whole blood collected in K2EDTA Plasma Preparation Tubes (PPT) will be acquired&#xD;
      via standard venipuncture.&#xD;
&#xD;
      This will be an observational study as subjects will only provide plasma specimens at&#xD;
      different time points and no therapeutic or intervention will be received outside of their&#xD;
      normal standard of care.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested&#xD;
             positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an&#xD;
             institutionally accepted assay.&#xD;
&#xD;
          2. Age of 18 years or older.&#xD;
&#xD;
          3. Participants are being considered for ALK-directed therapy or have progressed on EGFR&#xD;
             TKI treatment.&#xD;
&#xD;
          4. Participants must have hemoglobin &gt; 10 mg/dL.&#xD;
&#xD;
          5. Ability to understand and willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hepatitis (all types) in patient's medical record&#xD;
&#xD;
          2. HIV documented in patient's medical record&#xD;
&#xD;
          3. Hemoglobin &lt; 10 mg/dL&#xD;
&#xD;
          4. Less than 18 years of age&#xD;
&#xD;
          5. Histologically confirmed NSCLC Stage I-IIIA&#xD;
&#xD;
          6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger Tun</last_name>
    <role>Study Director</role>
    <affiliation>Exosome Diagnostics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Healthcare System</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 24, 2016</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT03236675
org study id: ECT2015-003A
nct id: NCT03236675
lead sponsor: 
has dmc: No
Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation
      from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.
The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK
      fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis,
      using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M
      EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis,
      using an institutionally accepted assay.
observational model: Cohort
time perspective: Prospective
measure: ALK mutation by tissue assay.
time frame: Two years
description: Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
measure: T790M EGFR mutation by tissue assay
time frame: Two years
description: Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
arm group label: EML4-ALK
description: ALK positive patients
arm group label: T790M EGFR
description: T790M positive patients
10-20 mL of whole blood collected in K2EDTA Plasma Preparation Tubes (PPT) will be acquired
      via standard venipuncture.

      This will be an observational study as subjects will only provide plasma specimens at
      different time points and no therapeutic or intervention will be received outside of their
      normal standard of care.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Roger Tun
role: Study Director
affiliation: Exosome Diagnostics, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Undecided