<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/NCT03258307</url>
  </required_header>
  <id_info>
    <org_study_id>900</org_study_id>
    <nct_id>NCT03258307</nct_id>
  </id_info>
  <brief_title>Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Pre-post Omentectomy</brief_title>
  <official_title>Comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone Levels Derivated From Adipose Tissue Pre-postoperatively in Patient Diagnosed With Gynecological Malignancy Performed Omentectomy or Not</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in&#xD;
      treatment of gynecological malignancy especially ovarian cancer and some advanced stage&#xD;
      endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone&#xD;
      secrete from adipose tissue. These regulate matabolic process.&#xD;
&#xD;
      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,&#xD;
      Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with&#xD;
      gynecological malignancy performed omentectomy or not&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in&#xD;
      treatment of gynecological malignancy especially ovarian cancer and some advanced stage&#xD;
      endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone&#xD;
      secrete from adipose tissue. These regulate matabolic process.&#xD;
&#xD;
      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,&#xD;
      Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with&#xD;
      gynecological malignancy performed omentectomy or not. Blood sample will study after 4000 rpm&#xD;
      centrifugal for 10 minutes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>with omentectomy group</measure>
    <time_frame>1 year</time_frame>
    <description>Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>No omentectomy group</measure>
    <time_frame>1 year</time_frame>
    <description>Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>omentectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preoperative</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omentectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Postoperative</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No omentectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Preoperative post operative</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preoperative level</intervention_name>
    <description>Blood sample</description>
    <arm_group_label>No omentectomy</arm_group_label>
    <arm_group_label>Omentectomy</arm_group_label>
    <arm_group_label>omentectomy</arm_group_label>
    <other_name>Postoperative level</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gynecologic malignancy, staging surgery with or without omentectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not accept inclusion to trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bakirkoy Dr Sadi Konuk Training and Research Hospital</name>
      <address>
        <city>İstanbul</city>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Isa Aykut Ozdemir</investigator_full_name>
    <investigator_title>Head of Department of Gynecologic Oncology Bakirkoy Dr Sadi Konuk Training and Research Hospital</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not share other researchers due to participant individual preference but when the research result publish researchers may obtain</ipd_description>
  </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/NCT03258307
org study id: 900
nct id: NCT03258307
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in
      treatment of gynecological malignancy especially ovarian cancer and some advanced stage
      endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
      secrete from adipose tissue. These regulate matabolic process.

      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,
      Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with
      gynecological malignancy performed omentectomy or not
Omentum is adipose tissue lying under inner anterior wall Omentectomy is routine procedure in
      treatment of gynecological malignancy especially ovarian cancer and some advanced stage
      endometrial cancer. Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
      secrete from adipose tissue. These regulate matabolic process.

      We aimed comparison of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin,
      Estrone levels derivated from adipose tissue pre-postoperatively in patient diagnosed with
      gynecological malignancy performed omentectomy or not. Blood sample will study after 4000 rpm
      centrifugal for 10 minutes
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: with omentectomy group
time frame: 1 year
description: Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
measure: No omentectomy group
time frame: 1 year
description: Pre-postoperative levels of Perilipin, Leptin, Adipolipin, Adiponectin, Resistin, Visfatin, Estrone
arm group label: omentectomy
arm group type: Active Comparator
description: Preoperative
arm group label: Omentectomy
arm group type: Other
description: Postoperative
arm group label: No omentectomy
arm group type: Other
description: Preoperative post operative
intervention type: Other
intervention name: Preoperative level
description: Blood sample
arm group label: No omentectomy
arm group label: Omentectomy
arm group label: omentectomy
other name: Postoperative level
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Training and Research Hospital
investigator full name: Isa Aykut Ozdemir
investigator title: Head of Department of Gynecologic Oncology Bakirkoy Dr Sadi Konuk Training and Research Hospital
sharing ipd: No
ipd description: IPD will not share other researchers due to participant individual preference but when the research result publish researchers may obtain