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/NCT05995808</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-02MD</org_study_id>
      <nct_id>NCT05995808</nct_id>
    </id_info>
    <brief_title>Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests</brief_title>
    <official_title>Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag 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>
        Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated&#xD;
        plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological&#xD;
        malignancies and takes the second place after non-Hodgkin lymphoma .&#xD;
  &#xD;
        There are some serological and clinical criteria that help to detect the stage of MM and&#xD;
        predict the patients' prognosis. These criteria include the level of M protein, calcium,&#xD;
        haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cycline D1 expression in bone marrow biopsy of multiple myeloma patient</measure>
      <time_frame>1 year</time_frame>
      <description>Cycline D1 expression in bone marrow biopsy of multiple myeloma patient</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>diagnostic group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bone marow biopsy and aspiration</intervention_name>
      <description>Bone marrow biopsy and biopsy aspiration</description>
      <arm_group_label>diagnostic group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>biochemical and heamatological tests</intervention_name>
      <description>complete blood count ,serum urea and creatinine</description>
      <arm_group_label>diagnostic group</arm_group_label>
      <other_name>complete blood count ,urea and creatinine in serum</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients older than 18 year with newly diagnosed MM.&#xD;
  &#xD;
            2. Approval to sign an informed written consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Fainan K EL Kady, spcialist</last_name>
      <phone>01063017967</phone>
      <email>fainan_khaled_post@med.sohag.edeu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Douaa M Sayed, professor</last_name>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Fainan Khaled Ahmed</investigator_full_name>
      <investigator_title>clinical pathology specialist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
    </condition_browse>
    <!-- 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/NCT05995808
  org study id: Soh-Med-23-07-02MD
  nct id: NCT05995808
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated
        plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological
        malignancies and takes the second place after non-Hodgkin lymphoma .
  
        There are some serological and clinical criteria that help to detect the stage of MM and
        predict the patients' prognosis. These criteria include the level of M protein, calcium,
        haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
  time frame: 1 year
  description: Cycline D1 expression in bone marrow biopsy of multiple myeloma patient
  arm group label: diagnostic group
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Bone marow biopsy and aspiration
  description: Bone marrow biopsy and biopsy aspiration
  arm group label: diagnostic group
  intervention type: Diagnostic Test
  intervention name: biochemical and heamatological tests
  description: complete blood count ,serum urea and creatinine
  arm group label: diagnostic group
  other name: complete blood count ,urea and creatinine in serum
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fainan K EL Kady, spcialist
  phone: 01063017967
  email: fainan_khaled_post@med.sohag.edeu.eg
  last name: Douaa M Sayed, professor
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Fainan Khaled Ahmed
  investigator title: clinical pathology specialist
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell