<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/NCT03025854</url>
  </required_header>
  <id_info>
    <org_study_id>2016-FXY-058</org_study_id>
    <nct_id>NCT03025854</nct_id>
  </id_info>
  <brief_title>Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma</brief_title>
  <official_title>Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guilin Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First People's Hospital of Foshan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical research project is to explore potential biomarkers and validate&#xD;
      the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
      Primary: Evaluation of failure-free survival after three years of patients of nasopharyngeal&#xD;
      carcinoma.&#xD;
&#xD;
      Secondary: Evaluation of overall survival after three years of patients of nasopharyngeal&#xD;
      carcinoma.&#xD;
&#xD;
      Outline: This is a multicenter observational study. Tumor tissue specimens are obtained from&#xD;
      the Sun Yat-sen University Cancer Center and Affiliated Hospital of Guilin Medical&#xD;
      University. The samples are analyzed for biomarkers. The biomarkers are correlated with&#xD;
      clinical outcomes (failure-free survival, overall survival, tumor response to treatment,&#xD;
      distant metastasis, recurrence and death).&#xD;
&#xD;
      The aim of the analysis is to explore potential biomarkers and validate the predictive and&#xD;
      prognostic value of molecular signature in nasopharyngeal carcinoma. This will lead to the&#xD;
      definition of risk groups and stratification of patients and will help to precision medicine&#xD;
      of nasopharyngeal carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Failure-free Survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood and tumor tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with newly histologically confirmed nasopharyngeal carcinoma and no evidence of&#xD;
        distant metastasis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly histologically confirmed nasopharyngeal carcinoma&#xD;
&#xD;
          -  No evidence of distant metastasis (M0)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with palliative intent&#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>Jun Ma, M.D.</last_name>
    <phone>+86-20-87343469</phone>
    <email>majun2@mail.sysu.edu.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>Jun Ma, M.D.</last_name>
      <phone>+86-20-87343469</phone>
      <email>majun2@mail.sysu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Jun Ma, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>October 9, 2020</last_update_submitted>
  <last_update_submitted_qc>October 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jun Ma, MD</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>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03025854
org study id: 2016-FXY-058
nct id: NCT03025854
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this clinical research project is to explore potential biomarkers and validate
      the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.
Objectives:

      Primary: Evaluation of failure-free survival after three years of patients of nasopharyngeal
      carcinoma.

      Secondary: Evaluation of overall survival after three years of patients of nasopharyngeal
      carcinoma.

      Outline: This is a multicenter observational study. Tumor tissue specimens are obtained from
      the Sun Yat-sen University Cancer Center and Affiliated Hospital of Guilin Medical
      University. The samples are analyzed for biomarkers. The biomarkers are correlated with
      clinical outcomes (failure-free survival, overall survival, tumor response to treatment,
      distant metastasis, recurrence and death).

      The aim of the analysis is to explore potential biomarkers and validate the predictive and
      prognostic value of molecular signature in nasopharyngeal carcinoma. This will lead to the
      definition of risk groups and stratification of patients and will help to precision medicine
      of nasopharyngeal carcinoma.
observational model: Cohort
time perspective: Prospective
measure: Failure-free Survival
time frame: 3 years
measure: Overall Survival
time frame: 3 years
Whole blood and tumor tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jun Ma, M.D.
phone: +86-20-87343469
email: majun2@mail.sysu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Jun Ma, MD
investigator title: Prof
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
sharing ipd: Undecided