<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/NCT03283228</url>
  </required_header>
  <id_info>
    <org_study_id>Myeloid Leukemia Markers</org_study_id>
    <nct_id>NCT03283228</nct_id>
  </id_info>
  <brief_title>Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia</brief_title>
  <official_title>Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      1. Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.&#xD;
&#xD;
        2. Study correlation between CD56 and CD11b expression with haematological parameters in&#xD;
           cases of adult AML.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. CD11b expression level is a prognostic biomarker for AML patient. CD11b positivity could&#xD;
           predict a poor prognosis for AML patients.&#xD;
&#xD;
        2. CD56 antigen expression, an inexpensive, easy to detect and reproduce index, is closely&#xD;
           related to the prognosis of AML patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CD11b and CD56 marker</measure>
    <time_frame>24 month</time_frame>
    <description>Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Adult Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>CD11b and CD56 markers</arm_group_label>
    <description>Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haematological parameters in cases of adult AML</arm_group_label>
    <description>Study correlation between CD56 and CD11b expression with haematological parameters in cases of adult AML</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cd11b and Cd56 markers</intervention_name>
    <description>The expression of CD11b and CD56 in newly diadnosed cases of AML</description>
    <arm_group_label>CD11b and CD56 markers</arm_group_label>
    <arm_group_label>Haematological parameters in cases of adult AML</arm_group_label>
    <other_name>Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anew diagnosis cases of adult AML&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Anew diagnosis cases of adult AML&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pediatric AML .&#xD;
&#xD;
          2. follow up cases of adult AML&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shaaban Helal, PHD</last_name>
    <phone>01005688567</phone>
    <email>Elhelal2007@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eman Salah Eldin, lecture</last_name>
    <phone>01028030966</phone>
    <email>Emansalah.eldin@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Z A Kamel</investigator_full_name>
    <investigator_title>Dr</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>
  <!-- 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/NCT03283228
org study id: Myeloid Leukemia Markers
nct id: NCT03283228
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.

        2. Study correlation between CD56 and CD11b expression with haematological parameters in
           cases of adult AML.
1. CD11b expression level is a prognostic biomarker for AML patient. CD11b positivity could
           predict a poor prognosis for AML patients.

        2. CD56 antigen expression, an inexpensive, easy to detect and reproduce index, is closely
           related to the prognosis of AML patients
observational model: Case-Control
time perspective: Cross-Sectional
measure: CD11b and CD56 marker
time frame: 24 month
description: Detect the expression of marker CD56 and CD11b in newly diagnosed cases of adult AML.
arm group label: CD11b and CD56 markers
description: Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia
arm group label: Haematological parameters in cases of adult AML
description: Study correlation between CD56 and CD11b expression with haematological parameters in cases of adult AML
intervention type: Diagnostic Test
intervention name: Cd11b and Cd56 markers
description: The expression of CD11b and CD56 in newly diadnosed cases of AML
arm group label: CD11b and CD56 markers
arm group label: Haematological parameters in cases of adult AML
other name: Cd11b and Cd56 as Prognostic Markers in Acute Myeloid Leukemia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Shaaban Helal, PHD
phone: 01005688567
email: Elhelal2007@gmail.com
last name: Eman Salah Eldin, lecture
phone: 01028030966
email: Emansalah.eldin@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Z A Kamel
investigator title: Dr
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute