<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/NCT03248310</url>
  </required_header>
  <id_info>
    <org_study_id>17-377</org_study_id>
    <nct_id>NCT03248310</nct_id>
  </id_info>
  <brief_title>A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management</brief_title>
  <official_title>A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</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>
      This study is being done to see the long-term results for patients who choose to have surgery&#xD;
      for lymphedema (with the vascularized lymph node transfer), compared to patients who choose&#xD;
      not to have surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>up to 40 months</time_frame>
    <description>Questionnaire to assess quality of life changes</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>vascularized lymph node transfer (VLNT)</arm_group_label>
    <description>This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-surgical treatment</arm_group_label>
    <description>This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality of Life Assessments</intervention_name>
    <description>Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.</description>
    <arm_group_label>non-surgical treatment</arm_group_label>
    <arm_group_label>vascularized lymph node transfer (VLNT)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who present for consultation of their lymphedema and who meet eligibility criteria&#xD;
        will be offered the option of enrolling in this study at the time of their initial&#xD;
        consultation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18-80 years&#xD;
&#xD;
          -  Primary and secondary lymphedema of the upper or lower extremity&#xD;
&#xD;
          -  International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema&#xD;
&#xD;
          -  Proficiency in English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless&#xD;
             they are on the non-surgical arm.&#xD;
&#xD;
          -  Additionally, if the patient refuses to complete questionnaires, the patient will be&#xD;
             excluded from the study and replaced at the discretion of the principal or&#xD;
             co-principal investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Joseph Dayan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joseph Dayan, MD</last_name>
    <phone>212-639-8095</phone>
    <email>dayanj@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Barrio, MD</last_name>
    <phone>646-888-5118</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester (Consent only)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Dayan, MD</last_name>
      <phone>212-639-8095</phone>
    </contact>
    <contact_backup>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5118</phone>
    </contact_backup>
    <investigator>
      <last_name>Joseph Dayan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Dayan, MD</last_name>
      <phone>212-639-8095</phone>
    </contact>
    <contact_backup>
      <last_name>Andrea Barrio, MD</last_name>
      <phone>646-888-5118</phone>
    </contact_backup>
    <investigator>
      <last_name>Joseph Dayan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of Life (QoL)</keyword>
  <keyword>17-377</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>


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/NCT03248310
org study id: 17-377
nct id: NCT03248310
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is being done to see the long-term results for patients who choose to have surgery
      for lymphedema (with the vascularized lymph node transfer), compared to patients who choose
      not to have surgery.
observational model: Case-Control
time perspective: Prospective
measure: Quality of Life
time frame: up to 40 months
description: Questionnaire to assess quality of life changes
arm group label: vascularized lymph node transfer (VLNT)
description: This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
arm group label: non-surgical treatment
description: This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
intervention type: Behavioral
intervention name: Quality of Life Assessments
description: Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
arm group label: non-surgical treatment
arm group label: vascularized lymph node transfer (VLNT)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Joseph Dayan, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Joseph Dayan, MD
phone: 212-639-8095
email: dayanj@mskcc.org
last name: Andrea Barrio, MD
phone: 646-888-5118
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Lymphedema
sharing ipd: Undecided