<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/NCT01688752</url>
  </required_header>
  <id_info>
    <org_study_id>2012NTLS086</org_study_id>
    <nct_id>NCT01688752</nct_id>
  </id_info>
  <brief_title>Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Cardiometabolic Status in Childhood Acute Lymphoblastic Leukemia, A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study assessing measures of cardiometabolic status, body&#xD;
      composition, IR and GH response to stimulation after therapy in children (age 7-21 years)&#xD;
      treated for ALL. Patients and sibling controls will be recruited from the Pediatric&#xD;
      Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia&#xD;
      (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency&#xD;
      matched by age and sex. Subjects in each group will have two visits. For cases, the first&#xD;
      visit will be approximately 6 months after completion of treatment for ALL; for their&#xD;
      siblings, the first visit occur at approximately the same time. For both cases and controls,&#xD;
      the second visit will be 2 to 2.5 years after the first visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding unavailable&#xD;
  </why_stopped>
  <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>Cardiometabolic Profile</measure>
    <time_frame>up to 2.5-3 Years</time_frame>
    <description>To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy [Visit 1]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of Blunted Stimulated Growth Hormone Response</measure>
    <time_frame>Between 2.5 and 3 Years</time_frame>
    <description>To determine the prevalence of blunted stimulated GH response suggesting GH deficiency (peak GH &lt;7mcg/L) in ALL survivors and controls: GH level will be obtained at baseline, then +30, +60, +90 and +120 minutes after clonidine (5 mcg/kg up to 200 mcg by mouth), followed by infusion of arginine (0.5 grams/kg up to 30 grams) with a series of GH levels at +140, +160, +180, +210, and +240 minutes. Blunted response to GH stimulation will be defined as peak GH level&lt;7 mcg/L.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>Sibling Controls</arm_group_label>
    <description>Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Lymphoblastic Leukemia Survivors</arm_group_label>
    <description>Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fasting blood samples will be obtained for lipids (total cholesterol, triglycerides, LDL-&#xD;
      cholesterol, HDL-cholesterol) insulin, glucose, inflammatory cytokines (CRP, IL-6, oxidized&#xD;
      LDL), leptin, adiponectin, insulin-like growth factor 1 (IGF-1), thyroid, and gonadal&#xD;
      function.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study entry is open to patients regardless of gender or ethnic background. While there will&#xD;
        be every effort to seek out and include females and minority patients, the patient&#xD;
        population is expected to be no different than the general pediatric oncology population&#xD;
        seen at the participating institutions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients&#xD;
&#xD;
               -  Age 7 years to less than or equal to 21 years at time of study enrollment.&#xD;
&#xD;
               -  Acute lymphoblastic leukemia (ALL) as first cancer diagnosis and in first&#xD;
                  complete remission. Any subtype is eligible.&#xD;
&#xD;
               -  Study enrollment must take place at/after six months of completion of all&#xD;
                  chemotherapy.&#xD;
&#xD;
               -  Patients must have a performance status corresponding to Eastern Cooperative&#xD;
                  Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients &gt; 16 years&#xD;
                  of age and Lansky for patients ≤ 16 years of age.&#xD;
&#xD;
               -  Any prior ALL therapy is allowable.&#xD;
&#xD;
          -  Siblings&#xD;
&#xD;
               -  Age 7 years to less than or equal to 21 years at time of study enrollment.&#xD;
&#xD;
               -  Sibling of ALL patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients&#xD;
&#xD;
               -  Diagnosis of diabetes mellitus prior to ALL diagnosis or at time of study&#xD;
                  enrollment.&#xD;
&#xD;
               -  Current pregnancy&#xD;
&#xD;
               -  Prior hematopoietic cell transplant.&#xD;
&#xD;
               -  Receiving growth hormone replacement or corticosteroids at the time of&#xD;
                  enrollment.&#xD;
&#xD;
          -  Siblings&#xD;
&#xD;
               -  Previously diagnosed with malignancy.&#xD;
&#xD;
               -  Diagnosis of diabetes mellitus.&#xD;
&#xD;
               -  Current pregnancy&#xD;
&#xD;
               -  Receiving growth hormone replacement or corticosteroids at the time of&#xD;
                  enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Steinberger, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masonic Cancer Center, University of Minnesota</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</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>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_browse>
  <!-- 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/NCT01688752
org study id: 2012NTLS086
nct id: NCT01688752
lead sponsor: 
has dmc: No
This is a prospective cohort study assessing measures of cardiometabolic status, body
      composition, IR and GH response to stimulation after therapy in children (age 7-21 years)
      treated for ALL. Patients and sibling controls will be recruited from the Pediatric
      Hematology-Oncology Clinic at the University of Minnesota Amplatz Children's Hospital.
This is a prospective cohort study with two groups: survivors of acute lymphoblastic leukemia
      (ALL) who have recently completed therapy (cases) and healthy siblings (controls) frequency
      matched by age and sex. Subjects in each group will have two visits. For cases, the first
      visit will be approximately 6 months after completion of treatment for ALL; for their
      siblings, the first visit occur at approximately the same time. For both cases and controls,
      the second visit will be 2 to 2.5 years after the first visit.
observational model: Cohort
time perspective: Prospective
measure: Cardiometabolic Profile
time frame: up to 2.5-3 Years
description: To determine the cardiometabolic profile (as measured by a single score based on adiposity, serum lipids, and vascular function) shortly after therapy (6 months after completion of therapy [Visit 1]) and again 2.5-3 yrs after completion of therapy (Visit 2) in 300 ALL patients, and compare with 200 sibling controls.
measure: Prevalence of Blunted Stimulated Growth Hormone Response
time frame: Between 2.5 and 3 Years
description: To determine the prevalence of blunted stimulated GH response suggesting GH deficiency (peak GH <7mcg/L) in ALL survivors and controls: GH level will be obtained at baseline, then +30, +60, +90 and +120 minutes after clonidine (5 mcg/kg up to 200 mcg by mouth), followed by infusion of arginine (0.5 grams/kg up to 30 grams) with a series of GH levels at +140, +160, +180, +210, and +240 minutes. Blunted response to GH stimulation will be defined as peak GH level<7 mcg/L.
arm group label: Sibling Controls
description: Healthy siblings of acute lymphoblastic leukemia (ALL) subjects frequency matched by age and sex.
arm group label: Acute Lymphoblastic Leukemia Survivors
description: Survivors of acute lymphoblastic leukemia (ALL) who recently completed therapy.
Fasting blood samples will be obtained for lipids (total cholesterol, triglycerides, LDL-
      cholesterol, HDL-cholesterol) insulin, glucose, inflammatory cytokines (CRP, IL-6, oxidized
      LDL), leptin, adiponectin, insulin-like growth factor 1 (IGF-1), thyroid, and gonadal
      function.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia Steinberger, MD, MS
role: Principal Investigator
affiliation: Masonic Cancer Center, University of Minnesota
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid