<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/NCT03003182</url>
  </required_header>
  <id_info>
    <org_study_id>2016-FXY-098-Dept. of RT</org_study_id>
    <nct_id>NCT03003182</nct_id>
  </id_info>
  <brief_title>A Study of Nasopharyngeal Carcinoma From Guangdong</brief_title>
  <official_title>A Prospective Cohort Study of Nasopharyngeal Carcinoma to Establish Prognostic Models, to Discover Toxicity Associated Predictors and to Validate Randomized Trials in Clinical Practice</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective cohort study aims to establish prognostic models, to discover toxicity&#xD;
      associated predictors and to validate randomized trials in clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 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>overall survival</measure>
    <time_frame>3-years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>30-days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Nasopharyngeal Cancer</condition>
  <arm_group>
    <arm_group_label>in clinical trials</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>out of clinical trials</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study includes patients with nasopharyngeal carcinoma in all stages.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histological confirmed nasopharyngeal carcinoma;&#xD;
&#xD;
          -  scanned by magnetic resonance imaging from calvaria vertex to clavicles before&#xD;
             treatment;&#xD;
&#xD;
          -  pretreatment Epstein-Barr virus deoxyribonucleic acid copy number is available;&#xD;
&#xD;
          -  irradiated with intensity-modulated radiotherapy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  finishing anticancer therapy in two or more hospitals;&#xD;
&#xD;
          -  pregnancy or lactation;&#xD;
&#xD;
          -  diagnosed with other sort of cancer before or during the treatment.&#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_contact>
    <last_name>Fang-Yun Xie, MD</last_name>
    <phone>+86-02087342618</phone>
    <email>xiefy@sysucc.org.cn</email>
  </overall_contact>
  <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>Fang-Yun Xie, M.D.</last_name>
      <phone>+86-020-87342618</phone>
      <email>xiefy@sysucc.org.cn</email>
    </contact>
    <contact_backup>
      <last_name>Pu-Yun OuYang, M.D.</last_name>
      <phone>+86-020-87342618</phone>
      <email>ouyangpy@sysucc.org.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>June 13, 2017</last_update_submitted>
  <last_update_submitted_qc>June 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Fang-Yun Xie</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</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/NCT03003182
org study id: 2016-FXY-098-Dept. of RT
nct id: NCT03003182
lead sponsor: 
has dmc: Yes
This prospective cohort study aims to establish prognostic models, to discover toxicity
      associated predictors and to validate randomized trials in clinical practice.
observational model: Cohort
time perspective: Prospective
measure: overall survival
time frame: 3-years
measure: Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
time frame: 30-days
arm group label: in clinical trials
arm group label: out of clinical trials
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Fang-Yun Xie, MD
phone: +86-02087342618
email: xiefy@sysucc.org.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Fang-Yun Xie
investigator title: Prof.
mesh term: Nasopharyngeal Carcinoma
mesh term: Nasopharyngeal Neoplasms
sharing ipd: No