<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/NCT01708421</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00037891</org_study_id>
    <nct_id>NCT01708421</nct_id>
  </id_info>
  <brief_title>Symptom Clusters in Children With Leukemia</brief_title>
  <official_title>Phenotypic and Genotypic Associations With Symptom Clusters During Childhood Leukemia Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the phenotypic and genotypic characteristics and&#xD;
      their associations with symptom clusters experienced during treatment for childhood leukemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A repeated measures research design will evaluate phenotypic and genotypic treatment-related&#xD;
      symptom associations experienced by children and adolescents 3-17 years of age with a&#xD;
      diagnosis of leukemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>
  <enrollment type="Actual">338</enrollment>
  <condition>Childhood Leukemia</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A baseline CSF sample will be obtained prior to intrathecal chemotherapy. CSF biomarkers will&#xD;
      be obtained at the initiation of post-induction, 4 and 6 months into post-induction therapy,&#xD;
      and at the start of maintenance therapy.A saliva sample will be obtained for genotypic&#xD;
      analysis at one of the four data collection times.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children between 3-18 years of age undergoing treatment for leukemia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phenotypic and genotypic treatment-related symptom associations will be evaluated in&#xD;
             children and adolescents 3-18 years of age with a diagnosis of leukemia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children without a definite diagnosis of leukemia will be excluded.&#xD;
&#xD;
          -  Children must be able to understand and answer the questions on the questionnaires.&#xD;
&#xD;
          -  Children with have a cognitive impairment (e.g. Down syndrome) will not be able to&#xD;
             complete the questionnaires and will not be eligible for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marilyn Hockenberyy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721-0203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospitals &amp; Clinics of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine/ Texas Children's Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2018</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>Syndrome</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/NCT01708421
org study id: Pro00037891
nct id: NCT01708421
lead sponsor: 
has dmc: Yes
The purpose of this study is to examine the phenotypic and genotypic characteristics and
      their associations with symptom clusters experienced during treatment for childhood leukemia.
A repeated measures research design will evaluate phenotypic and genotypic treatment-related
      symptom associations experienced by children and adolescents 3-17 years of age with a
      diagnosis of leukemia.
observational model: Cohort
time perspective: Prospective
A baseline CSF sample will be obtained prior to intrathecal chemotherapy. CSF biomarkers will
      be obtained at the initiation of post-induction, 4 and 6 months into post-induction therapy,
      and at the start of maintenance therapy.A saliva sample will be obtained for genotypic
      analysis at one of the four data collection times.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Marilyn Hockenberyy, PhD
role: Principal Investigator
affiliation: Duke University School of Nursing
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Syndrome