<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/NCT01719094</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00014375</org_study_id>
    <secondary_id>CCCWFU 99312</secondary_id>
    <nct_id>NCT01719094</nct_id>
  </id_info>
  <brief_title>RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors</brief_title>
  <official_title>RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer,&#xD;
      occurring at a significantly younger age than in the general population. The increased&#xD;
      incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and&#xD;
      mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover,&#xD;
      understanding of the mechanisms by which cancer treatment could influence the occurrence of&#xD;
      latent cardiovascular events is unavailable. Our group and others have established&#xD;
      independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in&#xD;
      middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes,&#xD;
      cardiac death, and congestive heart failure. The goal of this application is to show that&#xD;
      childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health&#xD;
      have increased aortic stiffness, when compared to healthy adolescent and young adult age&#xD;
      mate. Studies are designed to determine if MRI measures of cardiovascular function differ&#xD;
      between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and&#xD;
      adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The&#xD;
      investigators propose that MRI markers responsible for cardiovascular events represent new&#xD;
      clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine if aortic stiffness changes during treatment with anthracycline chemotherapy in childhood cancer patients</measure>
    <time_frame>approximately 6 months</time_frame>
    <description>n=25</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>if Aortic Stiffness</condition>
  <condition>Myocardial Wall Strain</condition>
  <arm_group>
    <arm_group_label>Childhood Cancer Surviviors</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Adolescent/young adults with no cancer history</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Newly diagnosed cancer patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Childhood cancer survivors, adolescent/young adults with no cancer history and newly&#xD;
        diagnosed cancer patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Childhood Cancer Survivors&#xD;
&#xD;
          -  Diagnosis of cancer at age 21 or younger&#xD;
&#xD;
          -  Current age 16-40 years&#xD;
&#xD;
          -  1year and ≤ 15 years from end of cancer treatment&#xD;
&#xD;
          -  Received anthracycline chemotherapy&#xD;
&#xD;
          -  Asymptomatic (Appendix VII: absence of palpitations, dyspnea, edema or anginal&#xD;
             symptoms)&#xD;
&#xD;
          -  No pre-existing diagnosis with regard to cardiovascular or cerebrovascular disease&#xD;
             status.&#xD;
&#xD;
        Adolescent/young adults with no cancer history&#xD;
&#xD;
          -  No prior diagnosis of cancer, diabetes, or lung disease&#xD;
&#xD;
          -  Current age 16-40 years&#xD;
&#xD;
          -  No history of radiation to chest or neck&#xD;
&#xD;
          -  No prior history of chemotherapy&#xD;
&#xD;
          -  Asymptomatic (Appendix VII : absence of palpitations, dyspnea, edema or anginal&#xD;
             symptoms) and without a pre-existing diagnosis with regard to cardiovascular or&#xD;
             cerebrovascular disease status.&#xD;
&#xD;
        Newly diagnosed cancer patients&#xD;
&#xD;
          -  Diagnosis of cancer at age 25 or younger&#xD;
&#xD;
          -  Current age 7-25 years&#xD;
&#xD;
          -  Planned receipt of anthracycline chemotherapy&#xD;
&#xD;
          -  Planned treatment course ≤ 15 months&#xD;
&#xD;
          -  No pre-existing cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All groups&#xD;
&#xD;
          -  Subjects with implanted electronic devices, including but not limited to: pacemakers,&#xD;
             defibrillators, functioning neurostimulator devices, or other implanted electronic&#xD;
             devices&#xD;
&#xD;
          -  Subjects with ferromagnetic cerebral aneurysm clips, or other&#xD;
             intraorbital/intracranial metal&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Subjects who received total body irradiation or cranial irradiation&#xD;
&#xD;
          -  History of acute myocardial infarction&#xD;
&#xD;
          -  Significant ventricular arrhythmias (&gt;20 PVC's/minute due to gating difficulty)&#xD;
&#xD;
          -  Medical history of moderate or severe aortic stenosis, or other significant valvular&#xD;
             disease&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Those with pre-existing history (by self report in Group B and review of medical&#xD;
             records in addition to self-report for Groups A &amp; C) of abnormal cardiovascular&#xD;
             function including: congenital heart disease, hypertension, diabetes,&#xD;
             hypercholesterolemia on treatment, a body mass index &gt;35, history of asymptomatic&#xD;
             cardiac dysfunction (defined as an ejection fraction &lt; 40 and/or shortening fraction &lt;&#xD;
             28) or symptomatic cardiac dysfunction (congestive heart failure), stroke, renal&#xD;
             dysfunction by history/medical records (serum creatinine &gt;1.4), anemia, obstructive or&#xD;
             restrictive airways disease&#xD;
&#xD;
          -  Asymptomatic cardiac dysfunction (defined as an ejection fraction &lt; 40 and/or&#xD;
             shortening fraction &lt; 28 on last ECHO or MUGA)&#xD;
&#xD;
          -  Participants unwilling to complete the protocol (1 visit for Group A, B; 3 scan&#xD;
             studies for Group C)&#xD;
&#xD;
          -  Participants unable to provide informed consent via a guardian or self&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon M Castellino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University School of Medicine</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forset University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>July 2, 2018</last_update_submitted>
  <last_update_submitted_qc>July 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2018</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/NCT01719094
org study id: IRB00014375
secondary id: CCCWFU 99312
nct id: NCT01719094
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer,
      occurring at a significantly younger age than in the general population. The increased
      incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and
      mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover,
      understanding of the mechanisms by which cancer treatment could influence the occurrence of
      latent cardiovascular events is unavailable. Our group and others have established
      independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in
      middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes,
      cardiac death, and congestive heart failure. The goal of this application is to show that
      childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health
      have increased aortic stiffness, when compared to healthy adolescent and young adult age
      mate. Studies are designed to determine if MRI measures of cardiovascular function differ
      between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and
      adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The
      investigators propose that MRI markers responsible for cardiovascular events represent new
      clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.
observational model: Case-Control
time perspective: Prospective
measure: To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy
time frame: Day 1
measure: To determine if aortic stiffness changes during treatment with anthracycline chemotherapy in childhood cancer patients
time frame: approximately 6 months
description: n=25
arm group label: Childhood Cancer Surviviors
arm group label: Adolescent/young adults with no cancer history
arm group label: Newly diagnosed cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon M Castellino, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
facility: 
country: United States
responsible party type: Sponsor