<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/NCT03249636</url>
  </required_header>
  <id_info>
    <org_study_id>MFARAG</org_study_id>
    <nct_id>NCT03249636</nct_id>
  </id_info>
  <brief_title>New Markers for Minimal Residual Disease in Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Evaluation of New Markers for Minimal Residual Disease in Precursor B Acute Lymphoblastic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the&#xD;
      overproduction and accumulation of cancerous, immature white blood cells, known as&#xD;
      lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as&#xD;
      red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating)&#xD;
      to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak&#xD;
      incidence at 2-5 years of age and another peak in old age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, new pieces of information obtained through immunophenotyping, cytogenetics&#xD;
      and genomic profiling. Chemotherapy resistance have contributed to a better understanding of&#xD;
      the pathology of this complex disorder and to recognition of subgroups of patients who&#xD;
      respond differently to therapy.&#xD;
&#xD;
      The possible impact of the expression of various markers has been studied in ALL.&#xD;
&#xD;
      In patients with acute leukemia, treatment decisions are based on the status of peripheral&#xD;
      blood and bone marrow cellularity. This provides a measure of the efficacy of therapy and can&#xD;
      reveal leukemia relapse. The reliability of morphologic examination of peripheral blood and&#xD;
      bone marrow largely depends on the hematologist's expertise, and its sensitivity is&#xD;
      fundamentally limited by the similarities in appearance between leukemic cells and normal&#xD;
      lympho-hematopoietic progenitors. Therefore, patients in complete morphologic remission may&#xD;
      still have a large number of residual leukemic cells (potentially up to 1010).&#xD;
&#xD;
      Minimal residual disease (MRD) is currently the most powerful prognostic indicator in&#xD;
      Precursor B acute lymphoblastic leukemia (B ALL). MRD analysis can be done by either ﬂow&#xD;
      cytometric or molecular techniques. Flow cytometric detection holds potential for wider&#xD;
      applicability than molecular techniques because ﬂow cytometric methods for leukemia diagnosis&#xD;
      are already established at most cancer centers worldwide.&#xD;
&#xD;
      Flow cytometric detection of MRD is based on the principle that ALL cells express&#xD;
      immunophenotypic features that can be used to distinguish them from normal hematopoietic&#xD;
      cells, including hematogones and activated lymphocytes commonly referred to as Leukemia&#xD;
      associated immunophenotype (LAIP). In virtually all patients with ALL, leukemia-associated&#xD;
      immunophenotypes can be deﬁned at diagnosis and then used to monitor MRD during treatment.&#xD;
&#xD;
      The reliability of ﬂow cytometric MRD assays depends on several factors. The most important&#xD;
      being the correct marker combination in use. Applicability is limited in some cases by the&#xD;
      lack of suitable leukemia associated immunophenotype (LAIP) with the currently used markers&#xD;
      and also antigen immunomodulation post treatment. Therefore, the identiﬁcation of new&#xD;
      leukemia markers that are easily detectable and are stably expressed in a large proportion of&#xD;
      ALL cases should simplify the application of MRD studies, help extend their beneﬁt to all&#xD;
      patients and possibly enhance the sensitivity of MRD detection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>15 Days</target_duration>
  <primary_outcome>
    <measure>Level of expression of markers in acute lymphoblastic leukemia.</measure>
    <time_frame>1 year</time_frame>
    <description>Level of expression of CD66c, CD 123 &amp; CD 73 in acute lymphocytic leukemia ,the correlation with each other .and with the clinical assessment of patients before and after induction</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>ALL patients</arm_group_label>
    <description>New cases of patients with acute lymphocytic leukemia. Evaluation of markers 15 days after induction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Flow cytometric analysis</intervention_name>
    <description>Level of expression of the markers and the correlation between the markers with each other and with the clinical presentation and impact on patients with ALL.</description>
    <arm_group_label>ALL patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        New cases of patients with acute lymphocytic leukemia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. New cases of patients with acute lymphocytic leukemia. 2. Evaluation of markers 15&#xD;
             days after induction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients died after induction&#xD;
&#xD;
          -  Patients diagnosed as Non Hodgkin Lymphoma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen R Farag, Resident</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rania M Bakry, Prof. Dr.</last_name>
    <phone>01013341395</phone>
    <email>rbakry.md@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Noha G Sayed, Dr.</last_name>
    <phone>01003305354</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Maureen R Farag</last_name>
      <phone>01018548568</phone>
      <email>maureen.farag@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Campana D, Coustan-Smith E. Measurements of treatment response in childhood acute leukemia. Korean J Hematol. 2012 Dec;47(4):245-54. doi: 10.5045/kjh.2012.47.4.245. Epub 2012 Dec 24.</citation>
    <PMID>23320002</PMID>
  </reference>
  <reference>
    <citation>Campana D, Behm FG. Immunophenotyping of leukemia. J Immunol Methods. 2000 Sep 21;243(1-2):59-75. doi: 10.1016/s0022-1759(00)00228-3.</citation>
    <PMID>10986407</PMID>
  </reference>
  <reference>
    <citation>Inaba H, Greaves M, Mullighan CG. Acute lymphoblastic leukaemia. Lancet. 2013 Jun 1;381(9881):1943-55. doi: 10.1016/S0140-6736(12)62187-4. Epub 2013 Mar 22.</citation>
    <PMID>23523389</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Maureen Farag</investigator_full_name>
    <investigator_title>Principal Investigator</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>Neoplasm, Residual</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/NCT03249636
org study id: MFARAG
nct id: NCT03249636
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute lymphoblastic leukemia , also known as acute lymphocytic leukemia, characterized by the
      overproduction and accumulation of cancerous, immature white blood cells, known as
      lymphoblasts, causing damage and death by inhibiting the production of normal cells (such as
      red and white blood cells and platelets) in the bone marrow and by spreading (infiltrating)
      to other organs. Acute lymphoblastic leukemia is most common in childhood, with a peak
      incidence at 2-5 years of age and another peak in old age.
In recent years, new pieces of information obtained through immunophenotyping, cytogenetics
      and genomic profiling. Chemotherapy resistance have contributed to a better understanding of
      the pathology of this complex disorder and to recognition of subgroups of patients who
      respond differently to therapy.

      The possible impact of the expression of various markers has been studied in ALL.

      In patients with acute leukemia, treatment decisions are based on the status of peripheral
      blood and bone marrow cellularity. This provides a measure of the efficacy of therapy and can
      reveal leukemia relapse. The reliability of morphologic examination of peripheral blood and
      bone marrow largely depends on the hematologist's expertise, and its sensitivity is
      fundamentally limited by the similarities in appearance between leukemic cells and normal
      lympho-hematopoietic progenitors. Therefore, patients in complete morphologic remission may
      still have a large number of residual leukemic cells (potentially up to 1010).

      Minimal residual disease (MRD) is currently the most powerful prognostic indicator in
      Precursor B acute lymphoblastic leukemia (B ALL). MRD analysis can be done by either ﬂow
      cytometric or molecular techniques. Flow cytometric detection holds potential for wider
      applicability than molecular techniques because ﬂow cytometric methods for leukemia diagnosis
      are already established at most cancer centers worldwide.

      Flow cytometric detection of MRD is based on the principle that ALL cells express
      immunophenotypic features that can be used to distinguish them from normal hematopoietic
      cells, including hematogones and activated lymphocytes commonly referred to as Leukemia
      associated immunophenotype (LAIP). In virtually all patients with ALL, leukemia-associated
      immunophenotypes can be deﬁned at diagnosis and then used to monitor MRD during treatment.

      The reliability of ﬂow cytometric MRD assays depends on several factors. The most important
      being the correct marker combination in use. Applicability is limited in some cases by the
      lack of suitable leukemia associated immunophenotype (LAIP) with the currently used markers
      and also antigen immunomodulation post treatment. Therefore, the identiﬁcation of new
      leukemia markers that are easily detectable and are stably expressed in a large proportion of
      ALL cases should simplify the application of MRD studies, help extend their beneﬁt to all
      patients and possibly enhance the sensitivity of MRD detection.
observational model: Cohort
time perspective: Prospective
measure: Level of expression of markers in acute lymphoblastic leukemia.
time frame: 1 year
description: Level of expression of CD66c, CD 123 & CD 73 in acute lymphocytic leukemia ,the correlation with each other .and with the clinical assessment of patients before and after induction
arm group label: ALL patients
description: New cases of patients with acute lymphocytic leukemia. Evaluation of markers 15 days after induction.
intervention type: Diagnostic Test
intervention name: Flow cytometric analysis
description: Level of expression of the markers and the correlation between the markers with each other and with the clinical presentation and impact on patients with ALL.
arm group label: ALL patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maureen R Farag, Resident
role: Principal Investigator
affiliation: Assiut University
last name: Rania M Bakry, Prof. Dr.
phone: 01013341395
email: rbakry.md@gmail.com
last name: Noha G Sayed, Dr.
phone: 01003305354
facility: 
contact: 
country: Egypt
citation: Campana D, Coustan-Smith E. Measurements of treatment response in childhood acute leukemia. Korean J Hematol. 2012 Dec;47(4):245-54. doi: 10.5045/kjh.2012.47.4.245. Epub 2012 Dec 24.
PMID: 23320002
citation: Campana D, Behm FG. Immunophenotyping of leukemia. J Immunol Methods. 2000 Sep 21;243(1-2):59-75. doi: 10.1016/s0022-1759(00)00228-3.
PMID: 10986407
citation: Inaba H, Greaves M, Mullighan CG. Acute lymphoblastic leukaemia. Lancet. 2013 Jun 1;381(9881):1943-55. doi: 10.1016/S0140-6736(12)62187-4. Epub 2013 Mar 22.
PMID: 23523389
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Maureen Farag
investigator title: Principal Investigator
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Neoplasm, Residual