<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/NCT03760237</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC48418</org_study_id>
    <nct_id>NCT03760237</nct_id>
  </id_info>
  <brief_title>Cardiovascular Function in Acute Leukemia</brief_title>
  <official_title>Cardiovascular Function in Leukemia Patients: an Observational Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</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>
      An observational, prospective study to describe the rates and predictors of cardiovascular&#xD;
      events in patients with acute leukemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be&#xD;
      enrolled and followed serially with blood collection, echocardiogram, arterial applanation&#xD;
      tonometry, and questionnaires for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Left Ventricular dysfunction</measure>
    <time_frame>1 year</time_frame>
    <description>defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Cardiovascular Events</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Symptomatic Heart Failure</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Cardiac Death and all mortality</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Leukemia, Myeloid, Acute</condition>
  <condition>Leukemia, Lymphoid, Acute</condition>
  <condition>Cardiotoxicity</condition>
  <arm_group>
    <arm_group_label>Acute Leukemia</arm_group_label>
    <description>Observation only. Patients newly diagnosed with acute leukemia who are scheduled to start treatment with chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation only</intervention_name>
    <description>No intervention, observational study only</description>
    <arm_group_label>Acute Leukemia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are newly diagnosed with acute leukemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years of age,&#xD;
&#xD;
          -  New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic&#xD;
             syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for&#xD;
             breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be&#xD;
             included).&#xD;
&#xD;
          -  Signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Cardiotoxicity</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/NCT03760237
org study id: UPCC48418
nct id: NCT03760237
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
An observational, prospective study to describe the rates and predictors of cardiovascular
      events in patients with acute leukemia.
Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be
      enrolled and followed serially with blood collection, echocardiogram, arterial applanation
      tonometry, and questionnaires for 1 year.
observational model: Cohort
time perspective: Prospective
measure: Left Ventricular dysfunction
time frame: 1 year
description: defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%.
measure: Incidence of Cardiovascular Events
time frame: 1 year
measure: Incidence of Symptomatic Heart Failure
time frame: 1 year
measure: Incidence of Cardiac Death and all mortality
time frame: 1 year
arm group label: Acute Leukemia
description: Observation only. Patients newly diagnosed with acute leukemia who are scheduled to start treatment with chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.
intervention type: Other
intervention name: observation only
description: No intervention, observational study only
arm group label: Acute Leukemia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Leukemia, Lymphoid
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Cardiotoxicity
sharing ipd: Undecided