<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/NCT03299478</url>
  </required_header>
  <id_info>
    <org_study_id>2016/714</org_study_id>
    <nct_id>NCT03299478</nct_id>
  </id_info>
  <brief_title>Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer</brief_title>
  <acronym>TNM-I</acronym>
  <official_title>Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northern Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital of North Norway</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 purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main aim is to validate the most promising T-cell marker candidates from earlier studies&#xD;
      in a prospective multicenter study to establish a prognostic TNM-Immunoscore.&#xD;
&#xD;
      The investigators will include around 1000 stage I-IIIA patients from various centers in&#xD;
      Scandinavia. The investigators will also collect demographic and clinicopathological data,&#xD;
      blood and tissues in a database and biobank. Candidate T-cell markers will be analyzed by&#xD;
      immunohistochemistry for validation and by other methods for exploration of their impact on&#xD;
      prognosis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 28, 2016</start_date>
  <completion_date type="Anticipated">February 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2027</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>Overall survival</measure>
    <time_frame>5 year follow-up</time_frame>
    <description>Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TTR</measure>
    <time_frame>5 year follow-up</time_frame>
    <description>Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific survival</measure>
    <time_frame>5 year follow-up</time_frame>
    <description>Disease specific survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">970</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>NSCLC patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Will look for immune infiltration</intervention_name>
    <arm_group_label>NSCLC patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor specimen Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pasients coming for resection of primary NSCLC with a curative intent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  resectable NSCLC&#xD;
&#xD;
          -  Age 18 and above&#xD;
&#xD;
          -  no other malignancy last 5 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple tumor foci&#xD;
&#xD;
          -  preoperative chemo- or radiotherapy&#xD;
&#xD;
          -  non-NSCLC histology&#xD;
&#xD;
          -  no tissue available for study&#xD;
&#xD;
          -  metastasis&#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>Lill-Tove R Busund, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sigve Andersen, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tom Dønnem, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>København</city>
        <state>København Ø</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <zip>9038</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Olav Hospital, University Hospital of Trondheim</name>
      <address>
        <city>Trondheim</city>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Norway</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <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/NCT03299478
org study id: 2016/714
nct id: NCT03299478
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung
      cancer.
The main aim is to validate the most promising T-cell marker candidates from earlier studies
      in a prospective multicenter study to establish a prognostic TNM-Immunoscore.

      The investigators will include around 1000 stage I-IIIA patients from various centers in
      Scandinavia. The investigators will also collect demographic and clinicopathological data,
      blood and tissues in a database and biobank. Candidate T-cell markers will be analyzed by
      immunohistochemistry for validation and by other methods for exploration of their impact on
      prognosis
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: 5 year follow-up
description: Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
measure: TTR
time frame: 5 year follow-up
description: Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
measure: Disease-specific survival
time frame: 5 year follow-up
description: Disease specific survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
arm group label: NSCLC patients
intervention type: Other
intervention name: Will look for immune infiltration
arm group label: NSCLC patients
Tumor specimen Blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lill-Tove R Busund, MD, PhD
role: Principal Investigator
affiliation: University Hospital of North Norway
last name: Sigve Andersen, MD,PhD
role: Principal Investigator
affiliation: University Hospital of North Norway
last name: Tom Dønnem, MD,PhD
role: Principal Investigator
affiliation: University Hospital of North Norway
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Norway
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No