<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/NCT04443400</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUTN</org_study_id>
    <nct_id>NCT04443400</nct_id>
  </id_info>
  <brief_title>Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy</brief_title>
  <official_title>Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      The purpose of this study is to detecte and predict early subclinical cardiac damage induced&#xD;
      by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography&#xD;
      combined with multiple circulating biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a monocentric prospective cohort study in which 100 patients treated for malignant&#xD;
      tumors and with cardiac radiation exposure will be included.All patient will be followed for&#xD;
      12 months after radiotherapy. Echocardiography, 2D STE parameters and circulating biomarkers&#xD;
      will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy</measure>
    <time_frame>2020-2021</time_frame>
    <description>To detecte early subclinical cardiac damage induced by thoracic radiation therapy, based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Radiation Therapy</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples will be collected&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with thoracic radiotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  with malignant tumors&#xD;
&#xD;
          -  will receive radiotherapy&#xD;
&#xD;
          -  with cardiac exposure during the radiotherapy process&#xD;
&#xD;
          -  could receive regular follow-up for 12 months&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  satisfactory echocardiographic images could not be obtained&#xD;
&#xD;
          -  moderate or severe valvular disease&#xD;
&#xD;
          -  cardiomyopathy&#xD;
&#xD;
          -  congenital heart disease&#xD;
&#xD;
          -  refractory hypertension&#xD;
&#xD;
          -  coronary artery disease*&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  arrhythmia requiring intervention&#xD;
&#xD;
          -  pericarditis&#xD;
&#xD;
          -  acute myocarditis&#xD;
&#xD;
          -  participating in other clinical studies of drug intervention&#xD;
&#xD;
          -  severe liver and kidney dysfunction&#xD;
&#xD;
          -  autoimmune disease&#xD;
&#xD;
          -  pulmonary hypertension&#xD;
&#xD;
        coronary artery disease: at least 50% stenosis besed on previous coronary angiography or&#xD;
        CTA, or with a history of percutaneous coronary stent implantation.&#xD;
&#xD;
        *: with LVEF&lt;50%, unstable angina，or acute myocardial infarction within 3 months.&#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_official>
    <last_name>Dan Zhu</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dan Zhu, M.D.</last_name>
    <phone>+8613810103532</phone>
    <phone_ext>+8613810103532</phone_ext>
    <email>andrea_zhu@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tingcui Li</last_name>
    <phone>+8618801236290</phone>
    <phone_ext>+8618801236290</phone_ext>
    <email>tingcui2019@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dan Zhu</last_name>
      <phone>+8613810103532</phone>
      <phone_ext>+8613810103532</phone_ext>
      <email>andrea_zhu@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Tingcui Li</last_name>
      <phone>+8618801236290</phone>
      <phone_ext>+8618801236290</phone_ext>
      <email>tingcui2019@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04443400
org study id: PekingUTN
nct id: NCT04443400
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to detecte and predict early subclinical cardiac damage induced
      by thoracic radiation therapy based on two-dimensional speckle tracking echocardiography
      combined with multiple circulating biomarkers.
This is a monocentric prospective cohort study in which 100 patients treated for malignant
      tumors and with cardiac radiation exposure will be included.All patient will be followed for
      12 months after radiotherapy. Echocardiography, 2D STE parameters and circulating biomarkers
      will be collected.
observational model: Cohort
time perspective: Prospective
measure: Early Detection of Cardiac Damage by Two-Dimensional Speckle Tracking Echocardiography After Thoracic Radiation Therapy
time frame: 2020-2021
description: To detecte early subclinical cardiac damage induced by thoracic radiation therapy, based on two-dimensional speckle tracking echocardiography combined with multiple circulating biomarkers
blood samples will be collected
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dan Zhu
role: Study Director
affiliation: Peking University Third Hospital
last name: Dan Zhu, M.D.
phone: +8613810103532
phone ext: +8613810103532
email: andrea_zhu@163.com
last name: Tingcui Li
phone: +8618801236290
phone ext: +8618801236290
email: tingcui2019@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor