<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/NCT02211677</url>
  </required_header>
  <id_info>
    <org_study_id>B2014-002-01</org_study_id>
    <nct_id>NCT02211677</nct_id>
  </id_info>
  <brief_title>Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma</brief_title>
  <official_title>Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction of TNM Staging System in Nasopharyngeal Carcinoma: A Prospective Multi-institutional Observation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RATIONALE&#xD;
&#xD;
        1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between&#xD;
           actual clinical outcome and TNM stages because it is an anatomy-based system in which&#xD;
           functional factors are not concerned.&#xD;
&#xD;
        2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve&#xD;
           prognosis prediction of TNM staging system in our previous retrospective study.&#xD;
&#xD;
      PURPOSE To validate that the prognostic index based on complete blood count and TNM system&#xD;
      had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system&#xD;
      alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be&#xD;
      divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their&#xD;
      prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups&#xD;
      of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until&#xD;
      death or the end of the study. Comparison on survivals of the 3 groups will be made to&#xD;
      validate the accuracy of the prognostic index. And comparison on prediction efficacy between&#xD;
      prognostic index and TNM staging system will be made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>5-year overall survival</measure>
    <time_frame>5 years after diagnosis</time_frame>
    <description>The period until any event (death, local recurrence or distant metastasis) is detected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-year disease-free survival</measure>
    <time_frame>5 years after diagnosis</time_frame>
    <description>The period until local recurrence or distant metastasis is detected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year recurrence-free survival</measure>
    <time_frame>5 years after diagnosis</time_frame>
    <description>The period until local recurrence is detected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year distant-free survival</measure>
    <time_frame>5 years after diagnosis</time_frame>
    <description>The period until distant metastasis is detected.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">720</enrollment>
  <condition>Nasopharyngeal Neoplasms</condition>
  <condition>Blood Cell Count</condition>
  <condition>Neoplasm Staging</condition>
  <condition>Prognosis</condition>
  <arm_group>
    <arm_group_label>Low Risk Group</arm_group_label>
    <description>Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hb, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 1-4 called the low risk group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate Risk Group</arm_group_label>
    <description>Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 5-11 called the intermediate risk group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Risk Group</arm_group_label>
    <description>Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 12-17 called the high risk group.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All the participants involved in our study are patients who are first diagnosed&#xD;
        nasopharyngeal carcinoma pathologically and treated with radical radiotherapy or&#xD;
        chemoradiotherapy in ourhospital from August 1st 2014 to July 31st 2015.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nasopharyngeal cancer patients diagnosed by pathology or cytology&#xD;
&#xD;
          -  UICC/AJCC 2010 Stage T1-4 N0-3 M0&#xD;
&#xD;
          -  Male or female patients with age between 18 and 75 years old&#xD;
&#xD;
          -  Karnofsky Performance Scores ≥ 60&#xD;
&#xD;
          -  Expected survival ≥ 3 months&#xD;
&#xD;
          -  Without dysfunction of heart, lung, liver, kidney and hematopoiesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Karnofsky Performance Status Score &lt; 70'&#xD;
&#xD;
          -  Radiotherapy uncompleted (≥ 1 fraction missing)&#xD;
&#xD;
          -  Distant metastases before or during radiotherapy&#xD;
&#xD;
          -  Without weekly complete blood count during radiotherapy&#xD;
&#xD;
          -  Application of colony stimulating factor such as erythropoietin&#xD;
&#xD;
          -  Signs of infection before radiotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yun-fei Xia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yun-fei Xia, MD</last_name>
    <phone>+8618665031162</phone>
    <email>xiayf@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hui Chang, MD</last_name>
    <phone>+8613480295989</phone>
    <email>changhui@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Fisrt Affiliated Hospital of Bengbu Medical College</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <zip>233004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Anhui Province Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yun-fei Xia, MD</last_name>
      <phone>+8618665031162</phone>
      <email>xiayf@sysucc.org.cn</email>
    </contact>
    <investigator>
      <last_name>Yun-fei Xia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hui Chang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>The Central Hospital of Shaoyang</name>
      <address>
        <city>Shaoyang</city>
        <state>Hunan</state>
        <zip>422000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Luzhou Medical College</name>
      <address>
        <city>Luzhou</city>
        <state>Sichuan</state>
        <zip>646000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>June 18, 2018</last_update_submitted>
  <last_update_submitted_qc>June 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Yun-fei Xia</investigator_full_name>
    <investigator_title>Department of Radiation Oncology, Sun Yat-sen University Cancer Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal 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/NCT02211677
org study id: B2014-002-01
nct id: NCT02211677
lead sponsor: 
has dmc: No
RATIONALE

        1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between
           actual clinical outcome and TNM stages because it is an anatomy-based system in which
           functional factors are not concerned.

        2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve
           prognosis prediction of TNM staging system in our previous retrospective study.

      PURPOSE To validate that the prognostic index based on complete blood count and TNM system
      had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system
      alone.
Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be
      divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their
      prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups
      of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until
      death or the end of the study. Comparison on survivals of the 3 groups will be made to
      validate the accuracy of the prognostic index. And comparison on prediction efficacy between
      prognostic index and TNM staging system will be made.
observational model: Cohort
time perspective: Prospective
measure: 5-year overall survival
time frame: 5 years after diagnosis
description: The period until any event (death, local recurrence or distant metastasis) is detected.
measure: 5-year disease-free survival
time frame: 5 years after diagnosis
description: The period until local recurrence or distant metastasis is detected.
measure: 5-year recurrence-free survival
time frame: 5 years after diagnosis
description: The period until local recurrence is detected.
measure: 5-year distant-free survival
time frame: 5 years after diagnosis
description: The period until distant metastasis is detected.
arm group label: Low Risk Group
description: Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hb, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 1-4 called the low risk group.
arm group label: Intermediate Risk Group
description: Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 5-11 called the intermediate risk group.
arm group label: High Risk Group
description: Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 12-17 called the high risk group.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yun-fei Xia, MD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Yun-fei Xia, MD
phone: +8618665031162
email: xiayf@sysucc.org.cn
last name: Hui Chang, MD
phone: +8613480295989
email: changhui@sysucc.org.cn
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Yun-fei Xia
investigator title: Department of Radiation Oncology, Sun Yat-sen University Cancer Center
mesh term: Neoplasms
mesh term: Nasopharyngeal Carcinoma
mesh term: Nasopharyngeal Neoplasms