<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/NCT03749512</url>
  </required_header>
  <id_info>
    <org_study_id>NLCR-01</org_study_id>
    <nct_id>NCT03749512</nct_id>
  </id_info>
  <brief_title>NLCR in Prediction of the Grade of Lung Tumor.</brief_title>
  <official_title>Preoperative Neutrophil-lymphocyte Count Ratio in Prediction of the Grade of Lung Tumor.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Silesia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from&#xD;
      the routine preoperative blood test may predict lung tumors' grading.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung cancer remains as one of the leading causes of death among oncology patients. Close&#xD;
      connection between inflammation and pathogenesis of some neoplasms was determined in a number&#xD;
      of studies. Some studies show promise that ratio of neutrophil to lymphocyte count (NLCR) may&#xD;
      be recognized as a prognostic marker for several carcinomas: renal, lung and colorectal. The&#xD;
      aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the&#xD;
      routine preoperative blood test may predict lung tumors' grading. During routine preoperative&#xD;
      blood tests complete blood count is done and NLCR, WBC, neutrophil and lymphocyte count is&#xD;
      noted. After the thoracic surgery intervention and histopathological examination grading of&#xD;
      lung tumor is noted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">November 16, 2018</completion_date>
  <primary_completion_date type="Actual">October 15, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neutrophil-lymphocyte count ratio</measure>
    <time_frame>From October 1, 2014 to October 15, 2018</time_frame>
    <description>Neutrophil-lymphocyte count ratio is measured during routine preoperative blood tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neutrophil count</measure>
    <time_frame>From October 1, 2014 to October 15, 2018</time_frame>
    <description>Neutrophil count is measured during routine preoperative blood tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphocyte count</measure>
    <time_frame>From October 1, 2014 to October 15, 2018</time_frame>
    <description>Lymphocyte count is measured during routine preoperative blood tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leucocyte count</measure>
    <time_frame>From October 1, 2014 to October 15, 2018</time_frame>
    <description>Leucocyte count is measured during routine preoperative blood tests.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Lung Neoplasm</condition>
  <arm_group>
    <arm_group_label>Observational Group</arm_group_label>
    <description>Group of patients with lung tumor qualified for thoracic surgery intervention with routine, preoperative complete blood count test and routine postoperative histopathological examination of lung tumor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Complete blood count</intervention_name>
    <description>During routine preoperative blood test complete blood count is taken.</description>
    <arm_group_label>Observational Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Histopathological examination</intervention_name>
    <description>Routine postoperative histopathological examination of lung tumor.</description>
    <arm_group_label>Observational Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive thoracic surgery patients admitted to SPSK nr 1 in Zabrze between October 2014&#xD;
        and October 2018 with lung tumor qualified for thoracic surgery intervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consecutive thoracic surgery patients with lung cancer grading confirmed by&#xD;
             histopathology postoperatively&#xD;
&#xD;
          -  preoperative routine complete blood count analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infectious disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  autoimmunologic disease&#xD;
&#xD;
          -  other known conditions or treatments that may influence the blood count&#xD;
             (seropositivity for HIV, chemotherapy, and corticotherapy)&#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>Hanna Misiołek, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of Silesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny nr 1</name>
      <address>
        <city>Zabrze</city>
        <state>Silesia</state>
        <zip>41-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Silesia</investigator_affiliation>
    <investigator_full_name>Piotr Palaczyński</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>NLCR, The neutrophil-lymphocyte count ratio, Lung Neoplasm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung 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/NCT03749512
org study id: NLCR-01
nct id: NCT03749512
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from
      the routine preoperative blood test may predict lung tumors' grading.
Lung cancer remains as one of the leading causes of death among oncology patients. Close
      connection between inflammation and pathogenesis of some neoplasms was determined in a number
      of studies. Some studies show promise that ratio of neutrophil to lymphocyte count (NLCR) may
      be recognized as a prognostic marker for several carcinomas: renal, lung and colorectal. The
      aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the
      routine preoperative blood test may predict lung tumors' grading. During routine preoperative
      blood tests complete blood count is done and NLCR, WBC, neutrophil and lymphocyte count is
      noted. After the thoracic surgery intervention and histopathological examination grading of
      lung tumor is noted.
observational model: Cohort
time perspective: Retrospective
measure: Neutrophil-lymphocyte count ratio
time frame: From October 1, 2014 to October 15, 2018
description: Neutrophil-lymphocyte count ratio is measured during routine preoperative blood tests.
measure: Neutrophil count
time frame: From October 1, 2014 to October 15, 2018
description: Neutrophil count is measured during routine preoperative blood tests.
measure: Lymphocyte count
time frame: From October 1, 2014 to October 15, 2018
description: Lymphocyte count is measured during routine preoperative blood tests.
measure: Leucocyte count
time frame: From October 1, 2014 to October 15, 2018
description: Leucocyte count is measured during routine preoperative blood tests.
arm group label: Observational Group
description: Group of patients with lung tumor qualified for thoracic surgery intervention with routine, preoperative complete blood count test and routine postoperative histopathological examination of lung tumor.
intervention type: Diagnostic Test
intervention name: Complete blood count
description: During routine preoperative blood test complete blood count is taken.
arm group label: Observational Group
intervention type: Other
intervention name: Histopathological examination
description: Routine postoperative histopathological examination of lung tumor.
arm group label: Observational Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hanna Misiołek, MD PhD
role: Study Chair
affiliation: Medical University of Silesia
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Silesia
investigator full name: Piotr Palaczyński
investigator title: Principal Investigator
mesh term: Lung Neoplasms