<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/NCT03286036</url>
  </required_header>
  <id_info>
    <org_study_id>PI12/02040</org_study_id>
    <nct_id>NCT03286036</nct_id>
  </id_info>
  <brief_title>Clinical and Molecular Staging of Lung Cancer Stages I and IIp</brief_title>
  <official_title>Clinical and Molecular Staging of Lung Cancer Stages I and IIp: Generation and Initial Analysis of a Clinical and Molecular Knowledge Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Consorcio Centro de Investigación Biomédica en Red (CIBER)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The classification of lung cancer (LC) according to the degree of anatomical extension (TNM)&#xD;
      allows the estimation of the prognosis of the patient, although its accuracy is limited. In&#xD;
      fact, one third of surgically-treated patients with initial disease have recurrences during&#xD;
      follow-up, despite the negativity of node dissection at surgery. The incorporation of&#xD;
      genetic, epigenetic and proteomic information to TNM staging will characterize more&#xD;
      accurately the lung cancer, and thereby improve the prognostic and the prediction of the&#xD;
      therapeutic response in these patients.In this project a prospective cohort of 320 patients&#xD;
      with lung cancer staged I-IIp will be studied, combining the clinical and pathologic&#xD;
      information available with genetic, epigenetic and proteomic markers in tumour samples,&#xD;
      pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the&#xD;
      application of complex analytical methodologies. Thus, a knowledge database will be created&#xD;
      with the aim of improving the prognostic and prediction capabilities of TNM staging.This&#xD;
      project is coordinated with related sub-projects that cover the required laboratory tests on&#xD;
      biological samples and with Spanish collaborative group in lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Cohort creation</measure>
    <time_frame>6 years</time_frame>
    <description>Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biological markers</measure>
    <time_frame>3 years</time_frame>
    <description>To identify biological variables with potential prognostic and / or predictive capacity of the therapeutic response, independent of the pathological TNM, in biological samples</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Lung cancer patients</arm_group_label>
    <description>Patients with lung cancer who undergo surgical resection of the tumor</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biomarkers</intervention_name>
    <description>This is an observational study, there is no intervention</description>
    <arm_group_label>Lung cancer patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tumoral tissue, non-tumoral tissue and blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Lung cancer patients who undergo surgical resection of their tumors in a Spanish hospital&#xD;
        with thoracic surgery and pathological anatomy departments&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18 years old&#xD;
&#xD;
          -  Able to understand and sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of mediastinal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Islas Baleares</state>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Monso E, Montuenga LM, Sanchez de Cos J, Villena C; Lung Cancer CIBERES-RTICC-SEPAR-Plataforma Biobanco Pulmonar. Biological Marker Analysis as Part of the CIBERES-RTIC Cancer-SEPAR Strategic Project on Lung Cancer. Arch Bronconeumol. 2015 Sep;51(9):462-7. doi: 10.1016/j.arbres.2014.11.010. Epub 2015 Jan 19. English, Spanish.</citation>
    <PMID>25614375</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Eduard Monsó-Molas</investigator_full_name>
    <investigator_title>Head of Respiratory Medicine Department</investigator_title>
  </responsible_party>
  <keyword>Biomarkers, early detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>This is a multicenter study and the patients' samples and clinical data will be available to the study collaborators when the recruitment finishes.</ipd_description>
  </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/NCT03286036
org study id: PI12/02040
nct id: NCT03286036
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The classification of lung cancer (LC) according to the degree of anatomical extension (TNM)
      allows the estimation of the prognosis of the patient, although its accuracy is limited. In
      fact, one third of surgically-treated patients with initial disease have recurrences during
      follow-up, despite the negativity of node dissection at surgery. The incorporation of
      genetic, epigenetic and proteomic information to TNM staging will characterize more
      accurately the lung cancer, and thereby improve the prognostic and the prediction of the
      therapeutic response in these patients.In this project a prospective cohort of 320 patients
      with lung cancer staged I-IIp will be studied, combining the clinical and pathologic
      information available with genetic, epigenetic and proteomic markers in tumour samples,
      pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the
      application of complex analytical methodologies. Thus, a knowledge database will be created
      with the aim of improving the prognostic and prediction capabilities of TNM staging.This
      project is coordinated with related sub-projects that cover the required laboratory tests on
      biological samples and with Spanish collaborative group in lung cancer.
observational model: Cohort
time perspective: Prospective
measure: Cohort creation
time frame: 6 years
description: Prospective cohort with detailed information of the clinical characteristics at the time of surgery and with biological samples
measure: Biological markers
time frame: 3 years
description: To identify biological variables with potential prognostic and / or predictive capacity of the therapeutic response, independent of the pathological TNM, in biological samples
arm group label: Lung cancer patients
description: Patients with lung cancer who undergo surgical resection of the tumor
intervention type: Other
intervention name: biomarkers
description: This is an observational study, there is no intervention
arm group label: Lung cancer patients
tumoral tissue, non-tumoral tissue and blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
facility: 
facility: 
facility: 
country: Spain
citation: Monso E, Montuenga LM, Sanchez de Cos J, Villena C; Lung Cancer CIBERES-RTICC-SEPAR-Plataforma Biobanco Pulmonar. Biological Marker Analysis as Part of the CIBERES-RTIC Cancer-SEPAR Strategic Project on Lung Cancer. Arch Bronconeumol. 2015 Sep;51(9):462-7. doi: 10.1016/j.arbres.2014.11.010. Epub 2015 Jan 19. English, Spanish.
PMID: 25614375
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Eduard Monsó-Molas
investigator title: Head of Respiratory Medicine Department
mesh term: Lung Neoplasms
sharing ipd: Yes
ipd description: This is a multicenter study and the patients' samples and clinical data will be available to the study collaborators when the recruitment finishes.