<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/NCT02193100</url>
  </required_header>
  <id_info>
    <org_study_id>BCC-BMT-13 Leuk Metabolomics</org_study_id>
    <nct_id>NCT02193100</nct_id>
  </id_info>
  <brief_title>Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center</brief_title>
  <official_title>PRE AND POST TREATMENT METABOLOMIC ANALYSIS OF LEUKEMIA: A Translational Clinical Trial of the Brown Cancer Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>James Graham Brown Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Louisville</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To characterize the metabolism of glucose by the leukemic cells in patients with leukemia&#xD;
      before and after initial chemotherapy.&#xD;
&#xD;
      To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells&#xD;
      in leukemic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum&#xD;
      metabolite analysis after C13-glucose administration at strategic time points of treatment.&#xD;
&#xD;
      To detect and measure 13C-labeled metabolic markers which may be present in the serum and&#xD;
      urine of leukemic patients.&#xD;
&#xD;
      To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum&#xD;
      metabolite analysis after C13-glucose administration at strategic time points of treatment.&#xD;
&#xD;
      To detect and measure 13C-labeled metabolic markers which may be present in the serum and&#xD;
      urine of leukemic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 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>
  <primary_outcome>
    <measure>Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)</measure>
    <time_frame>Baseline up to 6 months post treatment</time_frame>
    <description>Blood and urine samples will be taken before and after chemotherapy treatment for up to 6 months post treatment and analyzed for metabolic substances using nuclear magnetic resonance (NMR) spectroscopy with intergraded hyphenated mass spectrometry.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Leukemia</condition>
  <arm_group>
    <arm_group_label>13C-glucose</arm_group_label>
    <description>experimental (13C-glucose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No glucose</arm_group_label>
    <description>control (no glucose)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Leukemia Subjects-clinically diagnosed or histologically diagnosed leukemia Healthy&#xD;
        Subjects-no record of diagnosed cancer or hematologic disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Leukemia Subjects:&#xD;
&#xD;
          -  Each of the criteria in the following section must be met in order for a patient to be&#xD;
             eligible for enrollment.&#xD;
&#xD;
          -  Only patients with clinically diagnosed or histologically diagnosed leukemia will be&#xD;
             eligible to participate in this non-therapeutic study.&#xD;
&#xD;
          -  All patients must have measurable quantities of leukemic blasts on peripheral blood&#xD;
             detected with a CBC.&#xD;
&#xD;
          -  No history of diabetes for the experimental group or the control group.&#xD;
&#xD;
          -  Patients with known hepatitis C or HIV (AIDS) are excluded.&#xD;
&#xD;
          -  Patients must be informed of the investigational nature of this study and sign and&#xD;
             give written informed consent in accordance with institutional and federal guidelines.&#xD;
&#xD;
        Inclusion Criteria forHealthy Subjects:&#xD;
&#xD;
          -  Subjects must have no known prior history of cancer or malignant blood disorders.&#xD;
             -Where possible, follow up will be carried out to verify that no cancer has developed&#xD;
             since the blood collection. This will be done by a phone call performed one month from&#xD;
             sample to ask if new medical conditions have arisen.&#xD;
&#xD;
          -  Subjects must have WBC, RBC, and platelet counts within normal range on CBC.&#xD;
&#xD;
          -  Subjects with known hepatitis C or HIV (AIDS) are excluded.&#xD;
&#xD;
          -  No history of Diabetes&#xD;
&#xD;
          -  At least 30 years of age&#xD;
&#xD;
          -  Preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment&#xD;
&#xD;
          -  Patients must be informed of the investigational nature of this study and sign and&#xD;
             give written informed consent in accordance with institutional and federal guidelines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None listed in protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>James Graham Brown Cancer Center-University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>December 27, 2017</last_update_submitted>
  <last_update_submitted_qc>December 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2017</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>
  </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/NCT02193100
org study id: BCC-BMT-13 Leuk Metabolomics
nct id: NCT02193100
lead sponsor: 
collaborator: 
has dmc: Yes
To characterize the metabolism of glucose by the leukemic cells in patients with leukemia
      before and after initial chemotherapy.

      To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells
      in leukemic patients.
To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum
      metabolite analysis after C13-glucose administration at strategic time points of treatment.

      To detect and measure 13C-labeled metabolic markers which may be present in the serum and
      urine of leukemic patients.

      To characterize glycolytic metabolism in patients as demonstrated in leukemic cells and serum
      metabolite analysis after C13-glucose administration at strategic time points of treatment.

      To detect and measure 13C-labeled metabolic markers which may be present in the serum and
      urine of leukemic patients.
observational model: Cohort
time perspective: Prospective
measure: Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)
time frame: Baseline up to 6 months post treatment
description: Blood and urine samples will be taken before and after chemotherapy treatment for up to 6 months post treatment and analyzed for metabolic substances using nuclear magnetic resonance (NMR) spectroscopy with intergraded hyphenated mass spectrometry.
arm group label: 13C-glucose
description: experimental (13C-glucose)
arm group label: No glucose
description: control (no glucose)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia