<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/NCT03272646</url>
  </required_header>
  <id_info>
    <org_study_id>UNI Naples Vanvitelli</org_study_id>
    <nct_id>NCT03272646</nct_id>
  </id_info>
  <brief_title>Prognostic Performance of the Naples Prognostic Score</brief_title>
  <acronym>NPS</acronym>
  <official_title>The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer&#xD;
      patients undergoing surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The outcome of oncological patients is related not only to the tumor status but also to the&#xD;
      host. Particularly the patient's immune and nutritional status have been recently associated&#xD;
      with short- and long-term outcome in gastric and other cancers. In addition, there is growing&#xD;
      evidence that systemic inflammation plays a crucial role in the carcinogenesis and&#xD;
      progression of gastric cancer. The neutrophil to lymphocyte ratio (NLR), and, more recently,&#xD;
      the lymphocyte to monocyte ratio (LMR) have been shown to be independently correlated with&#xD;
      prognosis in patients with gastric cancer who underwent surgery, and preoperative albumin and&#xD;
      cholesterol levels seem to be adequate mirrors of the nutritional status of the host.&#xD;
&#xD;
      The investigators have already demonstrated that a new scoring system, which they called&#xD;
      Naples prognostic score (NPS), based on a composite score of albumin and cholesterol&#xD;
      concentrations, along with NLR and LMR is a simple tool strongly associated with long-term&#xD;
      outcome in patients undergoing surgery for colorectal cancer.&#xD;
&#xD;
      The aim of this study is to assess the correlation between the NPS and clinicopathological&#xD;
      characteristics, postoperative complication rate and long-term outcome in patients undergoing&#xD;
      surgery for gastric cancer. Furthermore, the new prognostic scoring system will be compared&#xD;
      with previously developed ones and the current TNM staging system to evaluate its&#xD;
      performance.&#xD;
&#xD;
      All patients who underwent surgery for proven gastric adenocarcinoma at the Division of&#xD;
      Surgical Oncology of the Gastrointestinal Tract of the University of Campania (Naples,&#xD;
      Italy), from January 2000 to December 2015 will be enrolled in the present study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2000</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>17 Years</target_duration>
  <primary_outcome>
    <measure>Prognostic performance of NPS.</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Corrlation between preoperative NPS and outcome (i.e. overall survival in all patients, and disease-free survival in radically resected patients). The prognostic performance of NPS will be compared to that of the prognostic nutritional index (PNI), the controlling nutritional status (CONUT) score, the systemic inflammation score (SIS), and the TNM staging system.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">477</enrollment>
  <condition>Nutritional and Metabolic Diseases</condition>
  <condition>Oncologic Disorders</condition>
  <arm_group>
    <arm_group_label>Group 1 or NPS = 0</arm_group_label>
    <description>Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 or NPS &gt;0 and &lt; 3</arm_group_label>
    <description>Patients undergoing surgery with NPS between 1 or 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 or NPS &gt; 2</arm_group_label>
    <description>Patients undergoing surgery with three or four alterations</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery</intervention_name>
    <description>gastric resection or total gastrectomy</description>
    <arm_group_label>Group 1 or NPS = 0</arm_group_label>
    <arm_group_label>Group 2 or NPS &gt;0 and &lt; 3</arm_group_label>
    <arm_group_label>Group 3 or NPS &gt; 2</arm_group_label>
    <other_name>radical surgery</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with proven gastric adenocarcinoma undergoing surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing surgery at our institution for proven gastric adenocarcinoma&#xD;
             will be enrolled in the present study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with lower esophageal adenocarcinoma or cancer crossing the esophagogastric&#xD;
             junction with its epicenter in the proximal 2 cm of stomach, which were taken apart&#xD;
             from stomach cancers in the last two AJCC cancer staging editions, will be excluded.&#xD;
&#xD;
          -  Patients with ongoing infections, concomitant immune-mediated diseases, or on drugs&#xD;
             capable of affecting neutrophil and/or lymphocyte counts (e.g., steroids,&#xD;
             immunosuppressants, etc.) will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gennaro Galizia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Campania 'Luigi Vanvitelli'</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Gennaro Galizia</investigator_full_name>
    <investigator_title>Full Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Gastric Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All data will be made available by contacting the principal investigator.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>at the end of the study</ipd_time_frame>
    <ipd_access_criteria>gennaro.galizia@unicampania.it</ipd_access_criteria>
  </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/NCT03272646
org study id: UNI Naples Vanvitelli
nct id: NCT03272646
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer
      patients undergoing surgery
The outcome of oncological patients is related not only to the tumor status but also to the
      host. Particularly the patient's immune and nutritional status have been recently associated
      with short- and long-term outcome in gastric and other cancers. In addition, there is growing
      evidence that systemic inflammation plays a crucial role in the carcinogenesis and
      progression of gastric cancer. The neutrophil to lymphocyte ratio (NLR), and, more recently,
      the lymphocyte to monocyte ratio (LMR) have been shown to be independently correlated with
      prognosis in patients with gastric cancer who underwent surgery, and preoperative albumin and
      cholesterol levels seem to be adequate mirrors of the nutritional status of the host.

      The investigators have already demonstrated that a new scoring system, which they called
      Naples prognostic score (NPS), based on a composite score of albumin and cholesterol
      concentrations, along with NLR and LMR is a simple tool strongly associated with long-term
      outcome in patients undergoing surgery for colorectal cancer.

      The aim of this study is to assess the correlation between the NPS and clinicopathological
      characteristics, postoperative complication rate and long-term outcome in patients undergoing
      surgery for gastric cancer. Furthermore, the new prognostic scoring system will be compared
      with previously developed ones and the current TNM staging system to evaluate its
      performance.

      All patients who underwent surgery for proven gastric adenocarcinoma at the Division of
      Surgical Oncology of the Gastrointestinal Tract of the University of Campania (Naples,
      Italy), from January 2000 to December 2015 will be enrolled in the present study.
observational model: Cohort
time perspective: Prospective
measure: Prognostic performance of NPS.
time frame: through study completion, an average of 1 year
description: Corrlation between preoperative NPS and outcome (i.e. overall survival in all patients, and disease-free survival in radically resected patients). The prognostic performance of NPS will be compared to that of the prognostic nutritional index (PNI), the controlling nutritional status (CONUT) score, the systemic inflammation score (SIS), and the TNM staging system.
arm group label: Group 1 or NPS = 0
description: Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.
arm group label: Group 2 or NPS >0 and < 3
description: Patients undergoing surgery with NPS between 1 or 2
arm group label: Group 3 or NPS > 2
description: Patients undergoing surgery with three or four alterations
intervention type: Procedure
intervention name: surgery
description: gastric resection or total gastrectomy
arm group label: Group 1 or NPS = 0
arm group label: Group 2 or NPS >0 and < 3
arm group label: Group 3 or NPS > 2
other name: radical surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Gennaro Galizia, MD
role: Principal Investigator
affiliation: University of Campania 'Luigi Vanvitelli'
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Gennaro Galizia
investigator title: Full Professor of Surgery
mesh term: Metabolic Diseases
sharing ipd: Yes
ipd description: All data will be made available by contacting the principal investigator.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: at the end of the study
ipd access criteria: gennaro.galizia@unicampania.it