<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/NCT04469543</url>
  </required_header>
  <id_info>
    <org_study_id>SCCCG-NHL2017</org_study_id>
    <nct_id>NCT04469543</nct_id>
  </id_info>
  <brief_title>A Retrospective Cohort Study: Influence of MTHFR C677T and A1298C Polymorphisms on the Survival of Pediatric Patients With Non-Hodgkin's Lymphoma</brief_title>
  <official_title>A Retrospective Cohort Study: Influence of MTHFR C677T and A1298C Polymorphisms on the Survival of Pediatric Patients With Non-Hodgkin's Lymphoma</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>
  <brief_summary>
    <textblock>
      The primary purpose of this retrospective study was to investigate the influence of&#xD;
      methylenetetrahydrofolate reductase (MTHFR) C677T/A1298C polymorphism on the survival of&#xD;
      pediatric patients with Non-Hodgkin lymphoma (NHL) treated with modified NHL-BFM95 protocol&#xD;
      in south China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2014</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 6, 2020</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>Death</measure>
    <time_frame>About six years</time_frame>
    <description>Overall survival time was calculated from the time of initial diagnosis to death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Events including progression, relapse, and secondary cancer</measure>
    <time_frame>About six years</time_frame>
    <description>Event-free survival (EFS) time was calculated from the time of initial diagnosis to first event.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">374</enrollment>
  <condition>Pediatric Non-Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>MTHFR polymorphism</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        We reviewed all the medical records of the patients who met the inclusion criteria in Sun&#xD;
        Yat-sen University Cancer Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged ≤ 18 years;&#xD;
&#xD;
          2. newly diagnosed as the four main categories of NHL(Burkitt's lymphoma, lymphoblastic&#xD;
             lymphoma, anaplastic large cell lymphoma, and diffuse large B-cell lymphoma) between&#xD;
             2014 and 2020;&#xD;
&#xD;
          3. treated according to the modified BFM95 protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. aged &gt; 18 years;&#xD;
&#xD;
          2. not newly diagnosed as the four main categories of NHL between 2014 and 2020;&#xD;
&#xD;
          3. treated according to chemotherapeutic regimens except for the modified BFM95 protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 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>Xiao-Fei Sun</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>MTHFR C677T polymorphism；A1298C; Pediatric Non-Hodgkin Lymphoma；Survival.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</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/NCT04469543
org study id: SCCCG-NHL2017
nct id: NCT04469543
lead sponsor: 
The primary purpose of this retrospective study was to investigate the influence of
      methylenetetrahydrofolate reductase (MTHFR) C677T/A1298C polymorphism on the survival of
      pediatric patients with Non-Hodgkin lymphoma (NHL) treated with modified NHL-BFM95 protocol
      in south China.
observational model: Cohort
time perspective: Retrospective
measure: Death
time frame: About six years
description: Overall survival time was calculated from the time of initial diagnosis to death
measure: Events including progression, relapse, and secondary cancer
time frame: About six years
description: Event-free survival (EFS) time was calculated from the time of initial diagnosis to first event.
arm group label: MTHFR polymorphism
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xiao-Fei Sun
investigator title: MD
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
sharing ipd: Undecided