<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/NCT02214134</url>
  </required_header>
  <id_info>
    <org_study_id>EORTC-1335-LCG-PBG</org_study_id>
    <nct_id>NCT02214134</nct_id>
  </id_info>
  <brief_title>SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access</brief_title>
  <acronym>SPECTAlung</acronym>
  <official_title>SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ETOP IBCSG Partners Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>European Organisation for Research and Treatment of Cancer - EORTC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the&#xD;
      molecular characteristics of their disease. The thoracic tumors include lung cancer,&#xD;
      malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular&#xD;
      characteristics are identified, there might be the possibility to offer these patients access&#xD;
      to targeted clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2015</start_date>
  <completion_date type="Actual">May 12, 2021</completion_date>
  <primary_completion_date type="Actual">October 22, 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>5 Years</target_duration>
  <primary_outcome>
    <measure>Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials.</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed.</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of exploratory/future research projects developped</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">539</enrollment>
  <condition>Any Stage of Lung Cancer (Any Histotype)</condition>
  <condition>Any Stage of Malignant Pleural Mesothelioma</condition>
  <condition>Any Stage of Any Thymic Malignancy</condition>
  <arm_group>
    <arm_group_label>Lung cancer</arm_group_label>
    <description>Patients with diagnosis of lung cancer at any stage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Malignant pleural mesothelioma</arm_group_label>
    <description>Patients with diagnosis of malignant pleural mesothelioma at any stage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thymic malignancy</arm_group_label>
    <description>Patients with diagnosis of thymic malignancy at any stage</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Tumour markers testing</intervention_name>
    <arm_group_label>Lung cancer</arm_group_label>
    <arm_group_label>Malignant pleural mesothelioma</arm_group_label>
    <arm_group_label>Thymic malignancy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      FFPE blocks of tumour tissue Blood samples Pleural effusion samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any&#xD;
        stage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed lung cancer, MPM, thymoma or thymic carcinoma at any stage;&#xD;
&#xD;
          -  Mandatory availability of adequate Human Biological Material (HBM): FFPE tissue sample&#xD;
             from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary&#xD;
             surgery or biopsy; minimal amount requested is detailed in the HBM guidelines;&#xD;
             inclusion of samples taken at any recurrence diagnosed during follow-up is strongly&#xD;
             encouraged but optional;&#xD;
&#xD;
          -  Centrally performed confirmation of tumor tissue adequacy in terms of quality/&#xD;
             quantity for central screening;&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  At least three months life-expectancy;&#xD;
&#xD;
          -  Written informed consent according to ICH/GCP and national/local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active malignancy, except pT1-2 prostatic cancer Gleason score &lt; 6, non&#xD;
             melanomatous skin cancer or carcinoma in situ of the cervix, in the 5 years before&#xD;
             study entry;&#xD;
&#xD;
          -  Active hepatitis B/C or HIV;&#xD;
&#xD;
          -  Any secondary malignancy;&#xD;
&#xD;
          -  Any severe organ dysfunction or other comorbidities that may prevent the inclusion&#xD;
             into clinical trials.&#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>Benjamin Besse, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.Z. Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Lyon - Hopital Louis Pradel</name>
      <address>
        <city>Lyon</city>
        <zip>69394</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assistance Publique - Hopitaux de Marseille - Hopital Nord</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Hopital Larrey</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy Cancer Campus</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. James's Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Luigi Gonzaga - Universita Di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Of Gdansk</name>
      <address>
        <city>Gdansk</city>
        <zip>80211</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Golnik</name>
      <address>
        <city>Golnik</city>
        <zip>4204</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 De Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>ES 28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois - Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>CH 1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois - Lausanne</name>
      <address>
        <city>Lausanne</city>
        <zip>CH1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - Kingston Hospital</name>
      <address>
        <city>Kingston upon Thames</city>
        <zip>KT2 7QB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - Chelsea, London</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - Sutton, Surrey</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>Malignant pleural mesothelioma</keyword>
  <keyword>Thymic malignancy</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Mesothelioma</mesh_term>
    <mesh_term>Mesothelioma, Malignant</mesh_term>
    <mesh_term>Thoracic Neoplasms</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/NCT02214134
org study id: EORTC-1335-LCG-PBG
nct id: NCT02214134
lead sponsor: 
collaborator: 
has dmc: Yes
SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the
      molecular characteristics of their disease. The thoracic tumors include lung cancer,
      malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular
      characteristics are identified, there might be the possibility to offer these patients access
      to targeted clinical trials.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials.
time frame: 5 years
measure: Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed.
time frame: 5 years
measure: Number of exploratory/future research projects developped
time frame: 5 years
arm group label: Lung cancer
description: Patients with diagnosis of lung cancer at any stage
arm group label: Malignant pleural mesothelioma
description: Patients with diagnosis of malignant pleural mesothelioma at any stage
arm group label: Thymic malignancy
description: Patients with diagnosis of thymic malignancy at any stage
intervention type: Genetic
intervention name: Tumour markers testing
arm group label: Lung cancer
arm group label: Malignant pleural mesothelioma
arm group label: Thymic malignancy
FFPE blocks of tumour tissue Blood samples Pleural effusion samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Besse, MD, PhD
role: Study Chair
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
facility: 
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country: Belgium
country: France
country: Ireland
country: Italy
country: Poland
country: Slovenia
country: Spain
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Mesothelioma
mesh term: Mesothelioma, Malignant
mesh term: Thoracic Neoplasms