<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/NCT01721252</url>
  </required_header>
  <id_info>
    <org_study_id>ICORG 08-41</org_study_id>
    <nct_id>NCT01721252</nct_id>
  </id_info>
  <brief_title>Tarceva. ICORG 08-41</brief_title>
  <official_title>Prospective Evaluation of a Proteomic Signature Developed to Identify Patients Likely to Benefit From Erlotinib (TarcevaTM), an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Used in the Treatment of Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Trials Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Trials Ireland</source>
  <brief_summary>
    <textblock>
      The aim of this study is to determine prospectively the value of a recently identified&#xD;
      proteomic signature in identifying those patients with lung cancer, who are likely to benefit&#xD;
      from and respond favourably to erlotinib therapy.&#xD;
&#xD;
      This is a prospective study of serum proteomics as a predictor of response to erlotinib&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening/Baseline&#xD;
&#xD;
        1. Routine blood tests (Haematology and Biochemistry) as per hospital practice&#xD;
&#xD;
        2. Research serum sample for proteomic studies (10ml blood sample)&#xD;
&#xD;
        3. Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size&#xD;
&#xD;
      2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment&#xD;
&#xD;
      4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment&#xD;
&#xD;
      1 year Post Commencement of Treatment with erlotinib (as per current standard of care):&#xD;
      Routine CT with RECIST/WHO assessment&#xD;
&#xD;
      Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy and&#xD;
      one year after treatment with erlotinib will be analyzed with the emphasis on identification&#xD;
      of disease progression.&#xD;
&#xD;
      Follow Up: Subsequent follow-up as per routine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <primary_completion_date type="Actual">August 2013</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>Value of a recently identified proteomic algorithm</measure>
    <time_frame>Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.</time_frame>
    <description>Routine CT with RECIST/WHO assessment</description>
  </primary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient (18 years of age or older) diagnosed with non-small cell lung cancer at any&#xD;
        stage who is to be treated with erlotinib.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Any patient who is suited to receive CT scans as part of his/her routine care&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent, given&#xD;
             according to ICH/GCP, and national/local regulations. A signed informed consent must&#xD;
             be obtained prior to any study specific procedures&#xD;
&#xD;
          -  Planned treatment with erlotinib.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18 years of age&#xD;
&#xD;
          -  Patients not foreseen to receive TarcevaTM treatment&#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>Cork University Hospital</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Adelaide &amp; Meath Hospital, Dublin, Incorporating the National Children's Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galway University Hospital</name>
      <address>
        <city>Galway</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Western Regional Hospital</name>
      <address>
        <city>Limerick</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Our Lady Of Lourdes Hospital, Drogheda</name>
      <address>
        <city>Louth</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>March 27, 2015</last_update_submitted>
  <last_update_submitted_qc>March 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>non-small cell lung cancer</keyword>
  <keyword>Erlotinib</keyword>
  <keyword>TarcevaTM</keyword>
  <keyword>proteomic signature</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/NCT01721252
org study id: ICORG 08-41
nct id: NCT01721252
lead sponsor: 
The aim of this study is to determine prospectively the value of a recently identified
      proteomic signature in identifying those patients with lung cancer, who are likely to benefit
      from and respond favourably to erlotinib therapy.

      This is a prospective study of serum proteomics as a predictor of response to erlotinib
      therapy.
Screening/Baseline

        1. Routine blood tests (Haematology and Biochemistry) as per hospital practice

        2. Research serum sample for proteomic studies (10ml blood sample)

        3. Routine pre-treatment CT but with formal RECIST/WHO measurements of tumour size

      2 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment

      4 months Post Commencement of Treatment with erlotinib: Routine CT with RECIST/WHO assessment

      1 year Post Commencement of Treatment with erlotinib (as per current standard of care):
      Routine CT with RECIST/WHO assessment

      Response Assessment: CT scans at baseline, at 2 and 4 months post commencement of therapy and
      one year after treatment with erlotinib will be analyzed with the emphasis on identification
      of disease progression.

      Follow Up: Subsequent follow-up as per routine.
observational model: Cohort
time perspective: Prospective
measure: Value of a recently identified proteomic algorithm
time frame: Change in CT scans taken at baseline, 2 and 4 months post commencement of therapy and one year after treatment with erlotinib will be analyzed with the emphasis on identification of disease progression.
description: Routine CT with RECIST/WHO assessment
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: 
facility: 
facility: 
facility: 
country: Ireland
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung