<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/NCT03035344</url>
  </required_header>
  <id_info>
    <org_study_id>CHILDHOOD ALL METABOLOMICS</org_study_id>
    <nct_id>NCT03035344</nct_id>
  </id_info>
  <brief_title>Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)</brief_title>
  <official_title>Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</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>
      Study of the intermediate metabolism in children diagnosed with ALL compared to healthy&#xD;
      matched controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary cause of this study is to investigate the changes that ALL may cause to the&#xD;
      metabolome of pediatric patients, in order to better understand its mechanism of action and&#xD;
      target metabolic pathways for potential therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls.</measure>
    <time_frame>Up to six months</time_frame>
    <description>The title of aminoacids in blood and urine and of organic acids in urine will be measured through Tandem Mass Spectrometry</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Acute Lymphoblastic Leukemia, Pediatric</condition>
  <condition>Metabolism Disorder</condition>
  <arm_group>
    <arm_group_label>ALL paediatric patients</arm_group_label>
    <description>Metabolome study in children diagnosed with ALL after bone marrow biopsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy matched controls</arm_group_label>
    <description>Metabolome study in healthy children matched for gender and age with the patients group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Metabolome study</intervention_name>
    <description>Metabolome study in ALL patients compared to healthy controls</description>
    <arm_group_label>ALL paediatric patients</arm_group_label>
    <arm_group_label>Healthy matched controls</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, urine, bone marrow&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children diagnosed with acute lymphoblastic leukemia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  Sex: all&#xD;
&#xD;
          -  Minimum age: 1 year&#xD;
&#xD;
          -  Maximum age: 16 years&#xD;
&#xD;
          -  The study accepts healthy volunteers as matched controls for the patinets.&#xD;
&#xD;
          -  Inclusion criteria: 1)Children diagnosed with ALL 2) Diagnosis confirmed with bone&#xD;
             marrow biopsy 3) Sampling before the initiation of therapy 4) Informed consent signed&#xD;
&#xD;
          -  Exclusion Criteria: 1) Children with a known chronic illness before ALL diagnosis 2)&#xD;
             ALL remission 3) Not signed informed consent&#xD;
&#xD;
          -  Population description: Patients are recruited from the Pediatric Hematology/Oncology&#xD;
             Department of Aristotle University of Thessaloniki (AHEPA hospital) and from the&#xD;
             Pediatric Hematology/ Oncology Department of Ippokration Hospital, that host all&#xD;
             children diagnosed with ALL in nothern Greece. Matched controls are recruited from&#xD;
             outpatient clinic of the 2nd and 4th Pediatric Department of Aristotle University of&#xD;
             Thessaloniki.&#xD;
&#xD;
          -  Sampling method: Non-probability sample&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Athanassios Evangeliou, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Aristotle University Of Thessaloniki</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria T. Papadopoulou, MD</last_name>
    <phone>6932343539</phone>
    <email>mtpapado@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Athanassios Evangeliou, Prof</last_name>
    <phone>00302313323916</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aristotle University of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria T. Papadopoulou, MD</last_name>
      <phone>+306932343539</phone>
      <email>mtpapado@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Maria T. Papadopoulou</investigator_full_name>
    <investigator_title>Principal investigator, MD, PhD candidate</investigator_title>
  </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>
    <mesh_term>Metabolic Diseases</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/NCT03035344
org study id: CHILDHOOD ALL METABOLOMICS
nct id: NCT03035344
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study of the intermediate metabolism in children diagnosed with ALL compared to healthy
      matched controls.
The primary cause of this study is to investigate the changes that ALL may cause to the
      metabolome of pediatric patients, in order to better understand its mechanism of action and
      target metabolic pathways for potential therapies.
observational model: Case-Control
time perspective: Prospective
measure: Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls.
time frame: Up to six months
description: The title of aminoacids in blood and urine and of organic acids in urine will be measured through Tandem Mass Spectrometry
arm group label: ALL paediatric patients
description: Metabolome study in children diagnosed with ALL after bone marrow biopsy
arm group label: Healthy matched controls
description: Metabolome study in healthy children matched for gender and age with the patients group
intervention type: Other
intervention name: Metabolome study
description: Metabolome study in ALL patients compared to healthy controls
arm group label: ALL paediatric patients
arm group label: Healthy matched controls
blood, urine, bone marrow
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 16 Years
healthy volunteers: No
last name: Athanassios Evangeliou, Prof
role: Study Chair
affiliation: Aristotle University Of Thessaloniki
last name: Maria T. Papadopoulou, MD
phone: 6932343539
email: mtpapado@gmail.com
last name: Athanassios Evangeliou, Prof
phone: 00302313323916
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Maria T. Papadopoulou
investigator title: Principal investigator, MD, PhD candidate
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Metabolic Diseases
sharing ipd: Undecided