<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/NCT01717105</url>
  </required_header>
  <id_info>
    <org_study_id>GGCP 048-10</org_study_id>
    <secondary_id>GGC-CPN-2010-01</secondary_id>
    <nct_id>NCT01717105</nct_id>
  </id_info>
  <brief_title>Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients</brief_title>
  <official_title>Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Gallego de Cancer de Pulmon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dynamic Solutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Gallego de Cancer de Pulmon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study has been designed in order to characterize the incidence of patients with&#xD;
      advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR)&#xD;
      positive mutations and their clinical management in Galicia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2011</start_date>
  <completion_date type="Anticipated">February 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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 epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia</measure>
    <time_frame>10 months (recruitment period)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening</measure>
    <time_frame>1 day (Screening Visit)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of epidermal growth factor receptor (EGFR) mutations: deletion in exon 19, point mutation at codon 858 (L858R) or other (only for EGFR M+ patients)</measure>
    <time_frame>1 day (Screening Visit)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)</measure>
    <time_frame>1 day (First study visit)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)</measure>
    <time_frame>From inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control (only for epidermal growth factor receptor (EGFR) M+ patients)</measure>
    <time_frame>From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)</measure>
    <time_frame>1 day (Progression Visit)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)</measure>
    <time_frame>1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epidermal growth factor receptor (EGFR) mutational status at disease progression in tumor tissue (primary tumor or metastatic samples) and plasma samples (only for EGFR M+ patients)</measure>
    <time_frame>1 day (Progresion Visit)</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">225</enrollment>
  <condition>Metastatic Non-Small-Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>metastatic non-small cell lung cancer</arm_group_label>
    <description>Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue Plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Outpatient consultation in oncology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria for patients´ screening:&#xD;
&#xD;
          -  Patients of both sexes aged 18 or more.&#xD;
&#xD;
          -  Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC)&#xD;
             (patients stage III B unsuitable for locoregional treatment, and stage IV).&#xD;
&#xD;
          -  Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first&#xD;
             line systemic cytotoxic chemotherapy).&#xD;
&#xD;
          -  Patients with available tumoral tissue (primary tumor or metastatic area) or&#xD;
             cytological samples including fine needle aspirates (primary tumor or metastatic&#xD;
             area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.&#xD;
&#xD;
          -  Patients who have granted their written informed consent.&#xD;
&#xD;
        Patients must fulfill the inclusion criteria previously mentioned and the following one in&#xD;
        order to be enrolled in the study (visit 1) for the follow-up until progression or until 9&#xD;
        months from the beginning of treatment have elapsed:&#xD;
&#xD;
        Inclusion Criteria for patients´ follow-up&#xD;
&#xD;
          -  Patients with documented positive mutation in epidermal growth factor receptor (EGFR)&#xD;
             (M+).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Combined histology of non-small cell and small cell lung cancer.&#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>Sergio Vázquez Estévez, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Grupo Gallego de Cáncer de Pulmón (GGCP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Complexo Hospitalario Arquitecto Marcide</name>
      <address>
        <city>Ferrol</city>
        <state>A Coruña</state>
        <zip>15405</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Ourense</name>
      <address>
        <city>Ourense</city>
        <state>Orense</state>
        <zip>32005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Meixoeiro</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Xeral-Cíes</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36204</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Povisa</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36211</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico de Galicia</name>
      <address>
        <city>A Coruña</city>
        <zip>15009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lucus Augusti Hospital</name>
      <address>
        <city>Lugo</city>
        <zip>27004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complexo Hospitalario de Pontevedra</name>
      <address>
        <city>Pontevedra</city>
        <zip>36071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-small cell lung cancer (NSCLC)</keyword>
  <keyword>Epidermal growth factor receptor (EGFR) positive mutation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT01717105
org study id: GGCP 048-10
secondary id: GGC-CPN-2010-01
nct id: NCT01717105
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The present study has been designed in order to characterize the incidence of patients with
      advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR)
      positive mutations and their clinical management in Galicia.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia
time frame: 10 months (recruitment period)
measure: Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening
time frame: 1 day (Screening Visit)
measure: Type of epidermal growth factor receptor (EGFR) mutations: deletion in exon 19, point mutation at codon 858 (L858R) or other (only for EGFR M+ patients)
time frame: 1 day (Screening Visit)
measure: Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)
time frame: 1 day (First study visit)
measure: Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)
time frame: From inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier.
measure: Disease control (only for epidermal growth factor receptor (EGFR) M+ patients)
time frame: From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up)
measure: Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)
time frame: 1 day (Progression Visit)
measure: Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)
time frame: 1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up
measure: Epidermal growth factor receptor (EGFR) mutational status at disease progression in tumor tissue (primary tumor or metastatic samples) and plasma samples (only for EGFR M+ patients)
time frame: 1 day (Progresion Visit)
arm group label: metastatic non-small cell lung cancer
description: Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments
Tumor tissue Plasma samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sergio Vázquez Estévez, Doctor
role: Study Director
affiliation: Grupo Gallego de Cáncer de Pulmón (GGCP)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung