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/NCT05992909</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0203</org_study_id>
      <secondary_id>NCI-2023-06282</secondary_id>
      <nct_id>NCT05992909</nct_id>
    </id_info>
    <brief_title>Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study</brief_title>
    <official_title>Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>M.D. Anderson Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>M.D. Anderson Cancer Center</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>
        To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery&#xD;
        rather than after a patient has already developed the disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objectives:&#xD;
  &#xD;
        The objective of this study is to evaluate the protective benefit to performing LVB surgery&#xD;
        at the time of ILND. In the secondary objective, we will compare the medical outcomes for&#xD;
        patients that received the LVB surgery with those receiving standard surgery in whom the&#xD;
        intervention could not be performed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03</measure>
      <time_frame>through study completion; an average of 1 year</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Lymphadenectomy</condition>
    <arm_group>
      <arm_group_label>Lymphovenous bypass procedure (LBP)</arm_group_label>
      <description>A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lymphovenous bypass procedure</intervention_name>
      <description>Participants will return to the clinic 14 days, 6 months, 12 months, 18 months, and 24 months after your surgery for measurements of your legs to see if there are changes over time</description>
      <arm_group_label>Lymphovenous bypass procedure (LBP)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          M D Anderson Cancer Center&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Eligibility Criteria:&#xD;
  &#xD;
            1. Patients greater than or equal to 18 years of age.&#xD;
  &#xD;
            2. Patients willing to participate.&#xD;
  &#xD;
            3. Patients able to complete informed consent.&#xD;
  &#xD;
            4. Patients undergoing ILND.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients taking anticoagulants within 7 days prior to surgery.&#xD;
  &#xD;
            2. Patients that are known to be pregnant at the time of surgery.&#xD;
  &#xD;
            3. Patients are available for follow-up less than 18 months or do not undergo&#xD;
               measurements within the scheduled period.&#xD;
  &#xD;
            4. Patients with BMI greater than 50.0.&#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_official>
      <last_name>Ashleigh Francis, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D. Anderson Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ashleigh Francis, MD</last_name>
      <phone>713-563-4598</phone>
      <email>amfrancis@mdanderson.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>MD Anderson Cancer Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mdanderson.org</url>
      <description>M D Anderson Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05992909
  org study id: 2023-0203
  secondary id: NCI-2023-06282
  nct id: NCT05992909
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery
        rather than after a patient has already developed the disease.
  Primary Objectives:
  
        The objective of this study is to evaluate the protective benefit to performing LVB surgery
        at the time of ILND. In the secondary objective, we will compare the medical outcomes for
        patients that received the LVB surgery with those receiving standard surgery in whom the
        intervention could not be performed.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
  time frame: through study completion; an average of 1 year
  arm group label: Lymphovenous bypass procedure (LBP)
  description: A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema
  intervention type: Procedure
  intervention name: Lymphovenous bypass procedure
  description: Participants will return to the clinic 14 days, 6 months, 12 months, 18 months, and 24 months after your surgery for measurements of your legs to see if there are changes over time
  arm group label: Lymphovenous bypass procedure (LBP)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ashleigh Francis, MD
  role: Principal Investigator
  affiliation: M.D. Anderson Cancer Center
  last name: Ashleigh Francis, MD
  phone: 713-563-4598
  email: amfrancis@mdanderson.org
  facility: 
  status: Recruiting
  country: United States
  url: http://www.mdanderson.org
  description: M D Anderson Cancer Center
  responsible party type: Sponsor