<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/NCT02975752</url>
  </required_header>
  <id_info>
    <org_study_id>EGFRdelEx 19 KRAS Exon 2</org_study_id>
    <nct_id>NCT02975752</nct_id>
  </id_info>
  <brief_title>EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA</brief_title>
  <acronym>EGFRdelEx19</acronym>
  <official_title>Rapid and Highly Sensitive EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA Specimen of Lymph Node Metastases From Patients With Lung Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      First-line treatment with afatinib prolongs overall survival in patients with metastatic&#xD;
      non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,&#xD;
      somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In&#xD;
      this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19&#xD;
      and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      First-line treatment with afatinib prolongs overall survival in patients with metastatic&#xD;
      non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,&#xD;
      somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid&#xD;
      availability of these biomarker results is mandatory to prevent delayed or inferior&#xD;
      treatments.&#xD;
&#xD;
      Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is&#xD;
      well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via&#xD;
      targeted resequencing allows simultaneous interrogation for multiple mutations, but has its&#xD;
      limitations based on the amount of tumor tissue required and assay times. RT-PCR using&#xD;
      Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations&#xD;
      in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is&#xD;
      feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to&#xD;
      compare results with results obtained via standard NGS mutation analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>detection of mutations</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">48</enrollment>
  <condition>Lung Adenocarcinoma Metastatic</condition>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>LC-RT-PCR and NGS</intervention_name>
    <description>highly sensitive PCR vs. multiplex targeted-resequencing</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EBUS-TBNA specimen of lymph nodes and primary tumor&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with suspected lung cancer on the chest CT-scan images receiving EBUS-TBNA&#xD;
        (endobronchial ultrasound-guided transbronchial needle aspiration) for clinical&#xD;
        pre-treatment workup of mediastinal and hilar lymph nodes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lung adenocarcinoma positive EBUS-TBNA specimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Filiz Özkan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Interventional Pneumology</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Essen</investigator_affiliation>
    <investigator_full_name>Filiz Oezkan</investigator_full_name>
    <investigator_title>Dr. med. Filiz Özkan</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02975752
org study id: EGFRdelEx 19 KRAS Exon 2
nct id: NCT02975752
lead sponsor: 
has dmc: No
First-line treatment with afatinib prolongs overall survival in patients with metastatic
      non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,
      somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In
      this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19
      and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).
First-line treatment with afatinib prolongs overall survival in patients with metastatic
      non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely,
      somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid
      availability of these biomarker results is mandatory to prevent delayed or inferior
      treatments.

      Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is
      well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via
      targeted resequencing allows simultaneous interrogation for multiple mutations, but has its
      limitations based on the amount of tumor tissue required and assay times. RT-PCR using
      Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations
      in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is
      feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to
      compare results with results obtained via standard NGS mutation analyses.
observational model: Cohort
time perspective: Retrospective
measure: detection of mutations
time frame: 1 year
intervention type: Genetic
intervention name: LC-RT-PCR and NGS
description: highly sensitive PCR vs. multiplex targeted-resequencing
EBUS-TBNA specimen of lymph nodes and primary tumor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Filiz Özkan, MD
role: Principal Investigator
affiliation: Department of Interventional Pneumology
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Essen
investigator full name: Filiz Oezkan
investigator title: Dr. med. Filiz Özkan
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma of Lung
sharing ipd: No