xml: <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/NCT05988047</url>
    </required_header>
    <id_info>
      <org_study_id>CMTM6_AML</org_study_id>
      <nct_id>NCT05988047</nct_id>
    </id_info>
    <brief_title>Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia</brief_title>
    <official_title>Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Freiburg</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Freiburg</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>
        In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain&#xD;
        containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will&#xD;
        use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2020</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>CMTM6 expression (FC)</measure>
      <time_frame>once at primary diagnosis</time_frame>
      <description>CMTM6 expression on blasts/monocytes will be measured by flow cytometry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>T cell activation (FC)</measure>
      <time_frame>once at primary diagnosis</time_frame>
      <description>T cell activation and cytokine production will be measured by flow cytometry</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CMTM6 expression (WB)</measure>
      <time_frame>once at primary diagnosis</time_frame>
      <description>CMTM6 expression on blasts/monocytes will be measured by Western blot</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Acute Myeloid Leukemia, Adult</condition>
    <arm_group>
      <arm_group_label>Patients with AML</arm_group_label>
      <description>Peripheral blood will be taken at the timepoint of primary diagnosis and analyzed for CMTM6 expression and T cell activation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy controls</arm_group_label>
      <description>Peripheral blood will be taken analyzed for CMTM6 expression and T cell activation</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with AML at primary diagnosis ≥ 18 years of age&#xD;
  &#xD;
          or&#xD;
  &#xD;
          healthy probands ≥ 18 years of age&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥ 18 years&#xD;
  &#xD;
            -  primary diagnosis of acute myeloid leukemia&#xD;
  &#xD;
            -  diagnosis results available&#xD;
  &#xD;
            -  written informed consent&#xD;
  &#xD;
            -  ability to understand the nature of the study and the study related procedures and to&#xD;
               comply with them&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt; 18 years&#xD;
  &#xD;
            -  lack of informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Robert Zeiser</last_name>
      <phone>+49 761 27034580</phone>
      <email>robert.zeiser@uniklinik-freiburg.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Natalie Koehler</last_name>
      <phone>+49 761 27071822</phone>
      <email>natalie.koehler@uniklinik-freiburg.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medical Center- University of Freiburg</name>
        <address>
          <city>Freiburg</city>
          <state>CA</state>
          <zip>79106</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Natalie Koehler</last_name>
        <phone>+49 761 27071822</phone>
        <email>natalie.koehler@uniklinik-freiburg.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Freiburg</investigator_affiliation>
      <investigator_full_name>Robert Zeiser</investigator_full_name>
      <investigator_title>Prof. Dr. med.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Leukemia, Myeloid</mesh_term>
      <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988047
  org study id: CMTM6_AML
  nct id: NCT05988047
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain
        containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will
        use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot.
  observational model: Cohort
  time perspective: Prospective
  measure: CMTM6 expression (FC)
  time frame: once at primary diagnosis
  description: CMTM6 expression on blasts/monocytes will be measured by flow cytometry
  measure: T cell activation (FC)
  time frame: once at primary diagnosis
  description: T cell activation and cytokine production will be measured by flow cytometry
  measure: CMTM6 expression (WB)
  time frame: once at primary diagnosis
  description: CMTM6 expression on blasts/monocytes will be measured by Western blot
  arm group label: Patients with AML
  description: Peripheral blood will be taken at the timepoint of primary diagnosis and analyzed for CMTM6 expression and T cell activation
  arm group label: Healthy controls
  description: Peripheral blood will be taken analyzed for CMTM6 expression and T cell activation
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  last name: Robert Zeiser
  phone: +49 761 27034580
  email: robert.zeiser@uniklinik-freiburg.de
  last name: Natalie Koehler
  phone: +49 761 27071822
  email: natalie.koehler@uniklinik-freiburg.de
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: University of Freiburg
  investigator full name: Robert Zeiser
  investigator title: Prof. Dr. med.
  mesh term: Leukemia
  mesh term: Leukemia, Myeloid
  mesh term: Leukemia, Myeloid, Acute
  sharing ipd: No