<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/NCT01728402</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00004422</org_study_id>
    <secondary_id>5R21CA159265</secondary_id>
    <nct_id>NCT01728402</nct_id>
  </id_info>
  <brief_title>Pathogenesis of Hematologic Malignancies</brief_title>
  <official_title>Pathogenesis of Acute Leukemia, Lymphoproliferative Disorders, and Myeloproliferative Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The cause of blood and bone marrow cancers is poorly understood; however, most research&#xD;
      focuses on how cancer cells grow and develop. Because the causes of these cancers are&#xD;
      unknown, current treatments may be unnecessarily harsh and often do not provide a cure.&#xD;
      Identifying the causes of blood cancers would allow for the development of treatments that&#xD;
      are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we&#xD;
      will look for specific cancer cell abnormalities that are responsible for cancer cell growth.&#xD;
      We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>September 2008</start_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>Identify and determine the frequency of mutations causing aberrant signaling pathway function in patients with acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN)</measure>
    <time_frame>After laboratory analyses are complete. Lab samples are collected at the time of a scheduled blood draw, bone marrow procedure, tissue biopsy, or other visit for usual medical care</time_frame>
    <description>Integrated functional genomics studies (whole genome sequencing, RNAi, proteomics, drug sensitivity, expression profiling) will be used to identify aberrant signaling pathways that contribute to the formation of hematologic malignancies.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Acute Leukemia</condition>
  <condition>Lymphoproliferative Disorders</condition>
  <condition>Myeloproliferative Disorders</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Blood Draw</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood draw, bone marrow procedure, or tissue biopsy</intervention_name>
    <arm_group_label>Blood Draw</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of any age with a diagnosis or suspected diagnosis of a blood or bone marrow&#xD;
        cancer may be a part of this study. The provider who will perform the blood draw, bone&#xD;
        marrow aspirate, or biopsy as part of the patient's routine care will identify possible&#xD;
        participants from their clinic schedule or patient list, give them information about what&#xD;
        would be involved in participating in the study including possible risks, and ask if they&#xD;
        are interested in participating.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected or confirmed diagnosis of AL, LPD, MDS, or MPD&#xD;
&#xD;
          -  Male or female of all ages&#xD;
&#xD;
          -  Willing and able to sign informed consent&#xD;
&#xD;
          -  Willing guardian consent for participants under 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No suspected or confirmed diagnosis of acute leukemias (AL), lymphoproliferative&#xD;
             disorders (LPD), myelodysplastic syndromes (MDS), or myeloproliferative diseases (MPD)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Loriaux, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Marc Loriaux</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Lymphoproliferative Disorders</mesh_term>
    <mesh_term>Myeloproliferative Disorders</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/NCT01728402
org study id: IRB00004422
secondary id: 5R21CA159265
nct id: NCT01728402
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The cause of blood and bone marrow cancers is poorly understood; however, most research
      focuses on how cancer cells grow and develop. Because the causes of these cancers are
      unknown, current treatments may be unnecessarily harsh and often do not provide a cure.
      Identifying the causes of blood cancers would allow for the development of treatments that
      are more likely to provide a cure. To find the causes of blood and bone marrow cancers, we
      will look for specific cancer cell abnormalities that are responsible for cancer cell growth.
      We will then look to see if drugs that can reverse these abnormalities can kill cancer cells.
observational model: Cohort
time perspective: Prospective
measure: Identify and determine the frequency of mutations causing aberrant signaling pathway function in patients with acute leukemias (AL), lymphoproliferative disorders (LPD), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN)
time frame: After laboratory analyses are complete. Lab samples are collected at the time of a scheduled blood draw, bone marrow procedure, tissue biopsy, or other visit for usual medical care
description: Integrated functional genomics studies (whole genome sequencing, RNAi, proteomics, drug sensitivity, expression profiling) will be used to identify aberrant signaling pathways that contribute to the formation of hematologic malignancies.
arm group label: Blood Draw
intervention type: Procedure
intervention name: blood draw, bone marrow procedure, or tissue biopsy
arm group label: Blood Draw
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Marc Loriaux, MD
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Marc Loriaux
investigator title: Associate Professor
mesh term: Leukemia
mesh term: Myelodysplastic Syndromes
mesh term: Lymphoproliferative Disorders
mesh term: Myeloproliferative Disorders