<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/NCT02226302</url>
  </required_header>
  <id_info>
    <org_study_id>FETCH</org_study_id>
    <nct_id>NCT02226302</nct_id>
  </id_info>
  <brief_title>Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer</brief_title>
  <acronym>FETCH</acronym>
  <official_title>Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queensland Centre for Gynaecological Cancer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queensland Institute of Medical Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Brisbane and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queensland Centre for Gynaecological Cancer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to develop an organotypic model to assess the effects of obesity on the&#xD;
      expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental&#xD;
      fat samples will be removed from participants during surgery and these fat samples will be&#xD;
      used in laboratory analyses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">August 2021</completion_date>
  <primary_completion_date type="Actual">May 2018</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>Identify estrogen-response genes in endometrial cancer</measure>
    <time_frame>Baseline</time_frame>
    <description>Omental fat will be collected from 6 lean patients, 6 obese patients and 4 controls (male patients) and co-cultured with endometrial cancer cell lines</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Examine how expression of estrogen response genes are altered in obesity</measure>
    <time_frame>Baseline</time_frame>
    <description>Compare gene response in tissue from lean and obese individuals</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Female Group 2</arm_group_label>
    <description>Females with BMI &gt;30 kg/m2 who are having a hysterectomy for benign conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Females Group 1</arm_group_label>
    <description>Females with BMI &lt;30 kg/m2 who are having a hysterectomy for benign conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Males</arm_group_label>
    <description>2 males with BMI &lt;30 kg/m2 and 2 males with BMI &gt;30 kg/m2</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Omental fat samples will be stored for one year for study purposes. They will not be stored&#xD;
      for future research&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        12 female patients undergoing surgery for pre-existent conditions will be recruited for&#xD;
        this study. The groups will include 6 patients with a BMI &lt; 30 kg/m2 and 6 patients with a&#xD;
        BMI ≥ 35 kg/m2. In addition 4 males patients will be recruited to assess responses from&#xD;
        patients with low levels of serum estradiol.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  Any patient having abdominal surgery (Laparoscopic or open technique) for benign&#xD;
             conditions&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Patients must have adequate:&#xD;
&#xD;
          -  Hematologic function: Neutrophils ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L&#xD;
&#xD;
          -  Renal function: serum creatinine ≤ ULN or estimated glomerular filtration rate (eGFR)&#xD;
             [CKD-EPI Formula] ≥ 60 mL/min&#xD;
&#xD;
          -  Hepatic function: serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN&#xD;
&#xD;
          -  Physically able to undergo surgery&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed gynaecological malignancy&#xD;
&#xD;
          -  Contraindications and/or unfit for Surgery: serious concomitant systemic disorders&#xD;
             incompatible with the study (at the discretion of the investigator);&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#xD;
&#xD;
          -  Serious illness or medical condition but not limited to, ongoing or active infection,&#xD;
             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia&#xD;
             (patients with stable AF are eligible), or psychiatric illness/social situations that&#xD;
             would limit compliance with study requirements.&#xD;
&#xD;
          -  Patients with disseminated intra-peritoneal malignancy or suspected ovarian cancer&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Previous bariatric surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donal Brennan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queensland Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth II Jubilee Hospital</name>
      <address>
        <city>Coopers Plains</city>
        <state>Queensland</state>
        <zip>4108</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrial cancer</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT02226302
org study id: FETCH
nct id: NCT02226302
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective is to develop an organotypic model to assess the effects of obesity on the
      expression and methylation status of estrogen-responsive genes in endometrial cancer. Omental
      fat samples will be removed from participants during surgery and these fat samples will be
      used in laboratory analyses.
observational model: Cohort
time perspective: Prospective
measure: Identify estrogen-response genes in endometrial cancer
time frame: Baseline
description: Omental fat will be collected from 6 lean patients, 6 obese patients and 4 controls (male patients) and co-cultured with endometrial cancer cell lines
measure: Examine how expression of estrogen response genes are altered in obesity
time frame: Baseline
description: Compare gene response in tissue from lean and obese individuals
arm group label: Female Group 2
description: Females with BMI >30 kg/m2 who are having a hysterectomy for benign conditions
arm group label: Females Group 1
description: Females with BMI <30 kg/m2 who are having a hysterectomy for benign conditions
arm group label: Males
description: 2 males with BMI <30 kg/m2 and 2 males with BMI >30 kg/m2
Omental fat samples will be stored for one year for study purposes. They will not be stored
      for future research
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Donal Brennan
role: Principal Investigator
affiliation: Queensland Health
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Obesity