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/NCT06009666</url>
    </required_header>
    <id_info>
      <org_study_id>07.01.2022.145</org_study_id>
      <nct_id>NCT06009666</nct_id>
    </id_info>
    <brief_title>Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema</brief_title>
    <official_title>Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marmara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Marmara 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>
        The aim of this study is to evaluate the feasibility of shear-wave elastography for the&#xD;
        diagnosis and staging of breast cancer related lymphedema by assessing the skin and&#xD;
        subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be&#xD;
        more easily applicable in daily life; and to investigate the relationship between the&#xD;
        patients' symptoms and elastographic measurements.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were&#xD;
        included in the study. The patients' demographic and clinical data were recorded. The&#xD;
        thickness and echogenicity of the skin and subcutaneous tissues of all extremities were&#xD;
        evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues&#xD;
        was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the&#xD;
        patients were compared both with each other and with the data of the control group.&#xD;
        Interobserver and intraobserver reliability analysis was performed for ultrasonography and&#xD;
        elastography measurements. The patients' pain, tension, weight, and stiffness symptoms&#xD;
        associated with lymphedema were questioned using a numerical scale. The patients'&#xD;
        functionality and participation in daily life activities were evaluated with the Quick DASH&#xD;
        and Life Impact Index questionnaires. The relationship between these findings and&#xD;
        elastographic and ultrasonographic parameters was analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">November 1, 2022</completion_date>
    <primary_completion_date type="Actual">April 1, 2022</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>B Mode Ultrasonography Measurements</measure>
      <time_frame>Day 0</time_frame>
      <description>Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Shear Wave Elastography Measurements</measure>
      <time_frame>Day 0</time_frame>
      <description>Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography</description>
    </primary_outcome>
    <primary_outcome>
      <measure>B Mode Ultrasonography Measurements</measure>
      <time_frame>Day 0</time_frame>
      <description>Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Association of USG and SWE Measurements With Symptoms</measure>
      <time_frame>Day 0</time_frame>
      <description>It is the relationship between the parameters evaluated by USG ( thickness in milimetres echogenity according to grading system) and SWE (stiffness in kilopascal) and the pain, tension, heaviness and stiffness scoring in which symptoms in numeric scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association of USG and SWE Measurements With Functionality</measure>
      <time_frame>Day 0</time_frame>
      <description>It is the relationship between the parameters evaluated by USG (thickhickness in milimetres , echogenity according to grading system) and SWE (stiffness in kilopascal) and QUİCK DASH Questionnaire Score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association of USG and SWE Measurements With Participation İn Daily Life</measure>
      <time_frame>Day 0</time_frame>
      <description>It is the relationship between the parameters evaluated by USG (thickness in milimetres ,echogenity according to grading system) and SWE (stiffness in kilopascal) and The Life İmpact Questionnaire Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association of USG and SWE Measurements With Volume Measurements</measure>
      <time_frame>Day 0</time_frame>
      <description>It is the volume measurement of both arms of the patients in cubic centimetre.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">72</enrollment>
    <condition>Lymphedema of Upper Arm</condition>
    <condition>Stiffness of Hand, Not Elsewhere Classified</condition>
    <condition>Evaluations, Diagnostic Self</condition>
    <arm_group>
      <arm_group_label>Patient Group</arm_group_label>
      <description>Both Extremities of Patients With Breast Cancer Related Lymphedema</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>Both Extremities of Healthy People With No History of Breast Cancer</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Shear Wave Elastography and B Mode Ultrasonography</intervention_name>
      <description>We evaluated the both upper extremities of the patient and control group with elastography and B mode ultrasonography. Shear wave elastography evaluates tissue deformation caused by acoustic radiation force. A highly focused ultrasound radiation is produced; The propagation speed of the shear wave depends on the stiffness of the tissue. It is a simple, inexpensive, bedside, widely available, non-invasive technique. B mode USG can be used to assess skin and subcutaneous tissue thickness and echogenicity. Skin and subcutaneous thickness were measured with b mode ultrasound. Skin and subcutaneous tissue stiffness was measured by shear wave ultrasonography</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Patient Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Quick Dash Questionnare</intervention_name>
      <description>Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. In the questionnaire, the difficulties of the patients during their daily living activities are questioned with 11 questions. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.</description>
      <arm_group_label>Patient Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>The Lymphedema Life Impact Scale</intervention_name>
      <description>The Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 functional subgroups. Each question is scored from 1 to 5, with higher scores indicating increased seriousness.</description>
      <arm_group_label>Patient Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Questioning lymphedema-related symptoms</intervention_name>
      <description>Arm pain and feeling of tension, heaviness and stiffness in the arm were evaluated separately by numerical scale. This scale is a 10 cm ruler that writes no pain, no tension, no heaviness, no stiffness on one side, and unbearable pain, tension and heaviness on the other side. Patients were asked to rate their associated symptoms on this scale between 0 and 10.</description>
      <arm_group_label>Patient Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Extremity circumference and volume measurement</intervention_name>
      <description>For the diagnosis of lymphedema, a detailed physical examination and extremity circumference were measured. This measurement was taken from both wrists to arm height with 4 cm intervals. Those with a circumference difference greater than 2 cm and/or no 10% volume difference were considered preclinical (latent) and those with clinical lymphedema.</description>
      <arm_group_label>Patient Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          In our study, individuals with breast cancer-related lymphedema diagnosis followed by&#xD;
          Marmara University Pendik Training and Research Hospital Physical Medicine and&#xD;
          Rehabilitation Department were included in the patient group, while upper extremity data of&#xD;
          healthy volunteers without a known lymphedema history were controlled by one-to-one&#xD;
          matching, considering the dominant and lymphedema sides of the patient group. included in&#xD;
          the group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For the patient group&#xD;
  &#xD;
            -  between the ages of 18-75&#xD;
  &#xD;
            -  diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy&#xD;
  &#xD;
            -  being stage 0-1-2 lymphedema according to ISL staging For the control group&#xD;
  &#xD;
            -  between the ages of 18-75&#xD;
  &#xD;
            -  no history of breast cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of surgery in the assessment area&#xD;
  &#xD;
            -  History of trauma at the assessment site&#xD;
  &#xD;
            -  Active infection in the assessment area&#xD;
  &#xD;
            -  Presence of congenital or acquired malformations at the assessment site&#xD;
  &#xD;
            -  Primary lymphedema&#xD;
  &#xD;
            -  those with any medical condition that may cause edema, such as advanced heart or&#xD;
               kidney failure&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>CANAN ŞANAL TOPRAK</last_name>
      <role>Study Chair</role>
      <affiliation>Marmara University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Canan Şanal-Toprak</name>
        <address>
          <city>İstanbul</city>
          <zip>34899</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphedema</mesh_term>
      <mesh_term>Breast Cancer Lymphedema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06009666
  org study id: 07.01.2022.145
  nct id: NCT06009666
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the feasibility of shear-wave elastography for the
        diagnosis and staging of breast cancer related lymphedema by assessing the skin and
        subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be
        more easily applicable in daily life; and to investigate the relationship between the
        patients' symptoms and elastographic measurements.
  Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were
        included in the study. The patients' demographic and clinical data were recorded. The
        thickness and echogenicity of the skin and subcutaneous tissues of all extremities were
        evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues
        was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the
        patients were compared both with each other and with the data of the control group.
        Interobserver and intraobserver reliability analysis was performed for ultrasonography and
        elastography measurements. The patients' pain, tension, weight, and stiffness symptoms
        associated with lymphedema were questioned using a numerical scale. The patients'
        functionality and participation in daily life activities were evaluated with the Quick DASH
        and Life Impact Index questionnaires. The relationship between these findings and
        elastographic and ultrasonographic parameters was analyzed.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: B Mode Ultrasonography Measurements
  time frame: Day 0
  description: Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG
  measure: Shear Wave Elastography Measurements
  time frame: Day 0
  description: Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography
  measure: B Mode Ultrasonography Measurements
  time frame: Day 0
  description: Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG
  measure: Association of USG and SWE Measurements With Symptoms
  time frame: Day 0
  description: It is the relationship between the parameters evaluated by USG ( thickness in milimetres echogenity according to grading system) and SWE (stiffness in kilopascal) and the pain, tension, heaviness and stiffness scoring in which symptoms in numeric scale.
  measure: Association of USG and SWE Measurements With Functionality
  time frame: Day 0
  description: It is the relationship between the parameters evaluated by USG (thickhickness in milimetres , echogenity according to grading system) and SWE (stiffness in kilopascal) and QUİCK DASH Questionnaire Score
  measure: Association of USG and SWE Measurements With Participation İn Daily Life
  time frame: Day 0
  description: It is the relationship between the parameters evaluated by USG (thickness in milimetres ,echogenity according to grading system) and SWE (stiffness in kilopascal) and The Life İmpact Questionnaire Scale
  measure: Association of USG and SWE Measurements With Volume Measurements
  time frame: Day 0
  description: It is the volume measurement of both arms of the patients in cubic centimetre.
  arm group label: Patient Group
  description: Both Extremities of Patients With Breast Cancer Related Lymphedema
  arm group label: Control Group
  description: Both Extremities of Healthy People With No History of Breast Cancer
  intervention type: Diagnostic Test
  intervention name: Shear Wave Elastography and B Mode Ultrasonography
  description: We evaluated the both upper extremities of the patient and control group with elastography and B mode ultrasonography. Shear wave elastography evaluates tissue deformation caused by acoustic radiation force. A highly focused ultrasound radiation is produced; The propagation speed of the shear wave depends on the stiffness of the tissue. It is a simple, inexpensive, bedside, widely available, non-invasive technique. B mode USG can be used to assess skin and subcutaneous tissue thickness and echogenicity. Skin and subcutaneous thickness were measured with b mode ultrasound. Skin and subcutaneous tissue stiffness was measured by shear wave ultrasonography
  arm group label: Control Group
  arm group label: Patient Group
  intervention type: Diagnostic Test
  intervention name: Quick Dash Questionnare
  description: Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. In the questionnaire, the difficulties of the patients during their daily living activities are questioned with 11 questions. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.
  arm group label: Patient Group
  intervention type: Diagnostic Test
  intervention name: The Lymphedema Life Impact Scale
  description: The Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 functional subgroups. Each question is scored from 1 to 5, with higher scores indicating increased seriousness.
  arm group label: Patient Group
  intervention type: Diagnostic Test
  intervention name: Questioning lymphedema-related symptoms
  description: Arm pain and feeling of tension, heaviness and stiffness in the arm were evaluated separately by numerical scale. This scale is a 10 cm ruler that writes no pain, no tension, no heaviness, no stiffness on one side, and unbearable pain, tension and heaviness on the other side. Patients were asked to rate their associated symptoms on this scale between 0 and 10.
  arm group label: Patient Group
  intervention type: Other
  intervention name: Extremity circumference and volume measurement
  description: For the diagnosis of lymphedema, a detailed physical examination and extremity circumference were measured. This measurement was taken from both wrists to arm height with 4 cm intervals. Those with a circumference difference greater than 2 cm and/or no 10% volume difference were considered preclinical (latent) and those with clinical lymphedema.
  arm group label: Patient Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: CANAN ŞANAL TOPRAK
  role: Study Chair
  affiliation: Marmara University
  facility: 
  facility: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Lymphedema
  mesh term: Breast Cancer Lymphedema
  sharing ipd: Undecided