<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/NCT04409379</url>
  </required_header>
  <id_info>
    <org_study_id>YL2019100602</org_study_id>
    <nct_id>NCT04409379</nct_id>
  </id_info>
  <brief_title>Association Between Telomere Length and Cardiac Dysfunction</brief_title>
  <official_title>Association Between Relative Telomere Length and Severity of Cardiac Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compelling epidemiological evidence indicates that alterations of relative telomere length&#xD;
      (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute&#xD;
      leukemia (AL).The aim of this study was to explore association between RTL content in&#xD;
      peripheral blood cells could be used as a risk predictor for severity of cardiac damage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Relative telomere length</measure>
    <time_frame>From date of admission until the date of discharging from hospital, assessed up to 5 days</time_frame>
    <description>The ratio of RTL to hemoglobin contents was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA contents.Relative expression of mtDNA were measured in young adults suffered from AL.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Cardiac Toxicity</condition>
  <condition>Acute Leukemia</condition>
  <condition>Childhood Cancer</condition>
  <arm_group>
    <arm_group_label>acute leukemia group</arm_group_label>
    <description>300 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Relative telomere length</intervention_name>
    <description>Relative telomere length in peripheral blood cell</description>
    <arm_group_label>acute leukemia group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Relative telomere length in peripheral blood cell&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 300 eligible acute leukemia patients were anticipated to include in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. histological confirmed acute leukemia; 2. Preparing for chemotherapy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.history of other malignancy; 2.blood transfusion within one month or prior bone&#xD;
             marrow transplantation; 3.patients who reluctant to sign informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xiao-Fan Zhu</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Lipeng Liu</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiotoxicity</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/NCT04409379
org study id: YL2019100602
nct id: NCT04409379
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Compelling epidemiological evidence indicates that alterations of relative telomere length
      (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute
      leukemia (AL).The aim of this study was to explore association between RTL content in
      peripheral blood cells could be used as a risk predictor for severity of cardiac damage.
observational model: Case-Control
time perspective: Prospective
measure: Relative telomere length
time frame: From date of admission until the date of discharging from hospital, assessed up to 5 days
description: The ratio of RTL to hemoglobin contents was calculated for each sample from standard curves. After that, the ratio for each sample was normalized to a calibrator DNA in order to standardize between different runs, and then defined as the measurement of relative mtDNA contents.Relative expression of mtDNA were measured in young adults suffered from AL.
arm group label: acute leukemia group
description: 300 patients were recruited, who have diagnosed with acute leukemia by bone marrow biopsy
intervention type: Diagnostic Test
intervention name: Relative telomere length
description: Relative telomere length in peripheral blood cell
arm group label: acute leukemia group
Relative telomere length in peripheral blood cell
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Lipeng Liu
investigator title: Dr.
mesh term: Cardiotoxicity
sharing ipd: No