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/NCT05967975</url>
    </required_header>
    <id_info>
      <org_study_id>Elastography and lymphoma</org_study_id>
      <nct_id>NCT05967975</nct_id>
    </id_info>
    <brief_title>Elastography and Treatment of Lymphoma</brief_title>
    <official_title>The Role of Sonoelastography in Evaluation of Therapeutic Response in Patients With Lymphoma.</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>
        To determine accuracy of elastography in assessment of superficial lymph nodes response to&#xD;
        treatment in cases of lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lymphomas are a heterogeneous group of malignancies that arise from the clonal proliferation&#xD;
        of lymphocytes. It represents approximately 5% of malignancies. Overall survival is estimated&#xD;
        to be 72%. (1)&#xD;
  &#xD;
        Lymphomas are broadly classified into Hodgkin lymphoma (HL) (10%) and Non-Hodgkin lymphoma&#xD;
        (NHL) (90%).&#xD;
  &#xD;
        HL is further classified into classical and non-classical types and NHL into B-cell, T-cell&#xD;
        and natural killer (NK) cell types. Diagnosis of lymphoma is confirmed by histopathology&#xD;
        (FNAC, True-cut or excisional biopsy).(2) The standard treatment of lymphoma is chemotherapy&#xD;
        and radiotherapy.&#xD;
  &#xD;
        The modalities used for staging and follow up of lymphoma are:&#xD;
  &#xD;
          -  Computed Tomography (CT) chest, abdomen and pelvis.&#xD;
  &#xD;
          -  Positron Emission Tomography (PET/CT).&#xD;
  &#xD;
          -  Whole body Magnetic Resonance Imaging (MRI).(3)&#xD;
  &#xD;
        Sonoelastography is a new technique that depends on the elastic properties of soft tissues,&#xD;
        with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a&#xD;
        dependable role in evaluation of therapeutic response in patients with lymphoma and can be&#xD;
        used for follow up, the same way it has been used in different parts of the body, such as the&#xD;
        breast, and thyroid. To the best of our knowledge, there are few studies concerning the role&#xD;
        of elastography in the field of lymphoma disease.(4)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</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>To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.</measure>
      <time_frame>Average three years</time_frame>
      <description>Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.</description>
    </primary_outcome>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Elastography</condition>
    <condition>Lymphoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed as lymphoma , have superficial lymph nodes and not received any&#xD;
          treatment&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients who are histopathologically proven as lymphoma, not receive treatment and&#xD;
               have superficial lymphadenopathy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1-Lymphoma without superficial lymph nodes. 2-patients under treatment.&#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>Kerols Refaat, Resident</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nagham Nabil, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Abdel-Monem Sayed, Lecture</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kero Refaat, Resident</last_name>
      <phone>+2 01110134427</phone>
      <email>kerolsrefaat13@gmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Kerols Refaat Ayoub</investigator_full_name>
      <investigator_title>Resident doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</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/NCT05967975
  org study id: Elastography and lymphoma
  nct id: NCT05967975
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To determine accuracy of elastography in assessment of superficial lymph nodes response to
        treatment in cases of lymphoma.
  Lymphomas are a heterogeneous group of malignancies that arise from the clonal proliferation
        of lymphocytes. It represents approximately 5% of malignancies. Overall survival is estimated
        to be 72%. (1)
  
        Lymphomas are broadly classified into Hodgkin lymphoma (HL) (10%) and Non-Hodgkin lymphoma
        (NHL) (90%).
  
        HL is further classified into classical and non-classical types and NHL into B-cell, T-cell
        and natural killer (NK) cell types. Diagnosis of lymphoma is confirmed by histopathology
        (FNAC, True-cut or excisional biopsy).(2) The standard treatment of lymphoma is chemotherapy
        and radiotherapy.
  
        The modalities used for staging and follow up of lymphoma are:
  
          -  Computed Tomography (CT) chest, abdomen and pelvis.
  
          -  Positron Emission Tomography (PET/CT).
  
          -  Whole body Magnetic Resonance Imaging (MRI).(3)
  
        Sonoelastography is a new technique that depends on the elastic properties of soft tissues,
        with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a
        dependable role in evaluation of therapeutic response in patients with lymphoma and can be
        used for follow up, the same way it has been used in different parts of the body, such as the
        breast, and thyroid. To the best of our knowledge, there are few studies concerning the role
        of elastography in the field of lymphoma disease.(4)
  observational model: Cohort
  time perspective: Prospective
  measure: To determine accuracy of elastography in assessment of superficial lymph nodes response to treatment in cases of lymphoma.
  time frame: Average three years
  description: Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in evaluation of therapeutic response in patients with lymphoma and can be used for follow up, the same way it has been used in different parts of the body, such as the breast, and thyroid. To the best of our knowledge, there are few studies concerning the role of elastography in the field of lymphoma disease.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Kerols Refaat, Resident
  role: Principal Investigator
  affiliation: Assiut University
  last name: Nagham Nabil, Professor
  role: Study Director
  affiliation: Assiut University
  last name: Abdel-Monem Sayed, Lecture
  role: Study Director
  affiliation: Assiut University
  last name: Kero Refaat, Resident
  phone: +2 01110134427
  email: kerolsrefaat13@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Kerols Refaat Ayoub
  investigator title: Resident doctor
  mesh term: Lymphoma