<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/NCT03790943</url>
  </required_header>
  <id_info>
    <org_study_id>SCCSS_cardiac_FU</org_study_id>
    <nct_id>NCT03790943</nct_id>
  </id_info>
  <brief_title>Cardiac Dysfunction in Childhood Cancer Survivors</brief_title>
  <acronym>Cardio-Onco</acronym>
  <official_title>Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Children's Hospital Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cantonal Hospital of St. Gallen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Luzerner Kantonsspital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bern</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>
      This multicenter, prospective cohort study evaluates early cardiac dysfunction in adult&#xD;
      survivors of childhood cancer. The hypothesis of this study is that cardiac dysfunction can&#xD;
      be detected earlier when using speckle tracking echocardiography as novel echocardiographic&#xD;
      technique compared to conventional echocardiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of&#xD;
      death in childhood cancer survivors. Early detection of cardiac dysfunction is important to&#xD;
      identify those in need for medical intervention to improve outcome. This study invites adult&#xD;
      childhood cancer survivors to a clinical appointment to the University Hospital Bern,&#xD;
      Switzerland. A detailed, standardized cardiac assessment including conventional and novel&#xD;
      echocardiographic techniques (speckle tracking) as well as cardiopulmonary exercise testing&#xD;
      is performed. Cardiac dysfunction is evaluated in survivors who have had cardiotoxic cancer&#xD;
      therapy with anthracyclines and/or chest radiation (high risk) and in survivors who have had&#xD;
      chemotherapy other than anthracyclines (standard risk).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 13, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Prevalence of cardiac dysfunction</measure>
    <time_frame>Baseline and longitudinal follow-up where clinically indicated</time_frame>
    <description>Conventional echocardiography: left ventricular ejection fraction (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of cardiac dysfunction</measure>
    <time_frame>Baseline and longitudinal follow-up where clinically indicated</time_frame>
    <description>Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of impaired exercise capacity</measure>
    <time_frame>Baseline</time_frame>
    <description>Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment-related risk factors</measure>
    <time_frame>Baseline</time_frame>
    <description>Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment-related risk factors</measure>
    <time_frame>Baseline</time_frame>
    <description>Dose of chest radiation (Gray)</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Cardiac Dysfunction</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Childhood Cancer</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>cardiac assessment</intervention_name>
    <description>Personal history, physical examination including anthropometry with hip/waist-ratio, electrocardiogram, echocardiography, 1-minute-sit-to-stand test, questionnaires on health-related quality of life (SF-36), diet, physical activity, and fatigue</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult survivors of childhood cancer, formerly treated at the University Children's Hospital&#xD;
        Bern or University Children's Hospital Basel or Children's Hospital of Eastern Switzerland&#xD;
        or Children´s Hospital Lucerne or University Hospitals of Geneva, with any chemotherapy&#xD;
        and/or chest radiation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        This prospective cohort study is nested within the Childhood Cancer Registry (ChCR), a&#xD;
        national, population-based cancer registry that includes all children and adolescents in&#xD;
        Switzerland who were diagnosed with cancer at age 0-20 years. It includes patients&#xD;
        diagnosed with leukemia, lymphoma, central nervous system tumors, and malignant solid&#xD;
        tumours or Langerhans cell histiocytosis. Childhood cancer survivors have survived at least&#xD;
        5 years from cancer diagnosis.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Registered in the ChCR&#xD;
&#xD;
          -  Formerly treated at the Department of Pediatric Hematology/Oncology of one of five&#xD;
             participating centers&#xD;
&#xD;
          -  Treated with any chemotherapy and/or chest radiation&#xD;
&#xD;
          -  Survived ≥ 5 years since most recent cancer diagnosis (primary cancer, relapse(s),&#xD;
             secondary cancer) at time of examination&#xD;
&#xD;
          -  Diagnosed at age ≤ 20 years&#xD;
&#xD;
          -  ≥ 18 years of age at time of study participation&#xD;
&#xD;
          -  Resident in Switzerland&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Study participants will be excluded if they do not meet the above mentioned inclusion&#xD;
             criteria or refuse to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia E Kuehni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudia E Kuehni, MD</last_name>
    <phone>+41 31 684 35 07</phone>
    <email>claudia.kuehni@unibe.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christina Schindera, MD</last_name>
    <phone>+41 31 684 37 71</phone>
    <email>christina.schindera@unibe.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Cardiology, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel-City</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriela Kuster, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institute of Social and Preventive Medicine, University of Bern</name>
      <address>
        <city>Bern</city>
        <state>BE</state>
        <zip>3012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephan Dobner, MD</last_name>
    </contact>
    <investigator>
      <last_name>Thomas Suter, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, University Hospitals of Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nana K Poku, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, Lucerne Cantonal Hospital</name>
      <address>
        <city>Lucerne</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reto Kurmann, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, Cantonal Hospital of St. Gallen</name>
      <address>
        <city>Saint Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eva Scheler, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Childhood cancer survivors</keyword>
  <keyword>Late effects</keyword>
  <keyword>Cardiotoxicity</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Anthracyclines</keyword>
  <keyword>Radiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT03790943
org study id: SCCSS_cardiac_FU
nct id: NCT03790943
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multicenter, prospective cohort study evaluates early cardiac dysfunction in adult
      survivors of childhood cancer. The hypothesis of this study is that cardiac dysfunction can
      be detected earlier when using speckle tracking echocardiography as novel echocardiographic
      technique compared to conventional echocardiography.
Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of
      death in childhood cancer survivors. Early detection of cardiac dysfunction is important to
      identify those in need for medical intervention to improve outcome. This study invites adult
      childhood cancer survivors to a clinical appointment to the University Hospital Bern,
      Switzerland. A detailed, standardized cardiac assessment including conventional and novel
      echocardiographic techniques (speckle tracking) as well as cardiopulmonary exercise testing
      is performed. Cardiac dysfunction is evaluated in survivors who have had cardiotoxic cancer
      therapy with anthracyclines and/or chest radiation (high risk) and in survivors who have had
      chemotherapy other than anthracyclines (standard risk).
observational model: Cohort
time perspective: Prospective
measure: Prevalence of cardiac dysfunction
time frame: Baseline and longitudinal follow-up where clinically indicated
description: Conventional echocardiography: left ventricular ejection fraction (%)
measure: Prevalence of cardiac dysfunction
time frame: Baseline and longitudinal follow-up where clinically indicated
description: Speckle tracking echocardiography: longitudinal (LS), circumferential (CS), and radial strain (RS)
measure: Prevalence of impaired exercise capacity
time frame: Baseline
description: Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production
measure: Treatment-related risk factors
time frame: Baseline
description: Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)
measure: Treatment-related risk factors
time frame: Baseline
description: Dose of chest radiation (Gray)
intervention type: Diagnostic Test
intervention name: cardiac assessment
description: Personal history, physical examination including anthropometry with hip/waist-ratio, electrocardiogram, echocardiography, 1-minute-sit-to-stand test, questionnaires on health-related quality of life (SF-36), diet, physical activity, and fatigue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia E Kuehni, MD
role: Principal Investigator
affiliation: University of Bern
last name: Claudia E Kuehni, MD
phone: +41 31 684 35 07
email: claudia.kuehni@unibe.ch
last name: Christina Schindera, MD
phone: +41 31 684 37 71
email: christina.schindera@unibe.ch
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: No