<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/NCT03027479</url>
  </required_header>
  <id_info>
    <org_study_id>PHAO16-LO/METERMUS-IMC</org_study_id>
    <secondary_id>2016-A01323-48</secondary_id>
    <secondary_id>2016-R27</secondary_id>
    <nct_id>NCT03027479</nct_id>
  </id_info>
  <brief_title>Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss</brief_title>
  <acronym>METERMUS-IMC</acronym>
  <official_title>Study of Differences in Skeletal Muscle Energy Metabolism Alterations in Women With Weight Loss and Ovarian and/or Endometrial Cancer Based on the Body Mass Index</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Inserm U1069 - Team Nutrition, Growth and Cancer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Tours</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 is to study skeletal muscle metabolism alterations métaboliques associated with&#xD;
      weight loss in women with ovarian and/or endometrial cancer according to BMI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 16, 2019</completion_date>
  <primary_completion_date type="Actual">July 16, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of muscle mitochondrial bioenergetics according to BMI</measure>
    <time_frame>muscle biopsy realized during surgery</time_frame>
    <description>Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>on muscle biopsy</measure>
    <time_frame>muscle biopsy realized during surgery</time_frame>
    <description>Quantification of lipids on electron microscope&#xD;
Type of muscular fibers&#xD;
Analyze of gene expression and proteins involved in 1/ Mitochondrial metabolism 2/ lipid metabolism and 3/ muscular proteolysis by RTqPCR with SyBR Green and Western Blot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>on white adipose tissue</measure>
    <time_frame>adipose tissue samples taken during surgery</time_frame>
    <description>adipose tissue composition (fatty acids quantification, sterols, steroids)&#xD;
RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profile and cytokines)&#xD;
RTqPCR analysis, western blot and immunohistochemical expression of markers of transformation into brown adipose tissue&#xD;
in specific milieu, in vitro experimentation on skeletal muscular cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>on ovarian cancer tumor samples</measure>
    <time_frame>ovarian tumor biopsies realized during surgery</time_frame>
    <description>lipid composition (fatty acids quantification, sterols, steroids)&#xD;
RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profil and cytokines)&#xD;
culture of tumour cells to evaluate resistance to chemotherapy (platinum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>on computerized tomography</measure>
    <time_frame>1 day of abdominal CT scan imaging procedure performed at diagnosis</time_frame>
    <description>assessment of body composition (fat and muscle compartments)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Weight Loss</condition>
  <condition>Ovarian Carcinoma</condition>
  <condition>Endometrial Carcinoma</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Samples</intervention_name>
    <description>Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample</description>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Case group selection criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 years old and more&#xD;
&#xD;
          -  Ovarian and/or endometrial cancer&#xD;
&#xD;
          -  weight loss related to cancer (weight loss &gt; 5% weight in one month or 10% in 6&#xD;
             months)&#xD;
&#xD;
          -  Indication to therapeutic surgery&#xD;
&#xD;
          -  Women affiliated to social security scheme&#xD;
&#xD;
          -  Women who can understand French and able to sign Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unbalanced Diabetes&#xD;
&#xD;
          -  Chronic neuromuscular disorder&#xD;
&#xD;
          -  Any severe uncontrolled medical condition&#xD;
&#xD;
        Control group selection criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 years and more&#xD;
&#xD;
          -  Surgery Indication for a benign endometrial and/ or ovarian disease&#xD;
&#xD;
          -  Patient affiliated to social security scheme&#xD;
&#xD;
          -  Women who can understand French and able to sign Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unbalanced Diabetes&#xD;
&#xD;
          -  Chronic neuromuscular disorder&#xD;
&#xD;
          -  Any severe uncontrolled medical condition&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lobna OULDAMER, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Teaching Hospital of Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gynecology Department, University Teaching Hospital, Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>weight loss</keyword>
  <keyword>ovarian cancer</keyword>
  <keyword>endometrial cancer</keyword>
  <keyword>energy metabolism</keyword>
  <keyword>Body mass index</keyword>
  <keyword>obesity</keyword>
  <keyword>muscle energy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03027479
org study id: PHAO16-LO/METERMUS-IMC
secondary id: 2016-A01323-48
secondary id: 2016-R27
nct id: NCT03027479
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the aim is to study skeletal muscle metabolism alterations métaboliques associated with
      weight loss in women with ovarian and/or endometrial cancer according to BMI.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Measurement of muscle mitochondrial bioenergetics according to BMI
time frame: muscle biopsy realized during surgery
description: Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy
measure: on muscle biopsy
time frame: muscle biopsy realized during surgery
description: Quantification of lipids on electron microscope
Type of muscular fibers
Analyze of gene expression and proteins involved in 1/ Mitochondrial metabolism 2/ lipid metabolism and 3/ muscular proteolysis by RTqPCR with SyBR Green and Western Blot
measure: on white adipose tissue
time frame: adipose tissue samples taken during surgery
description: adipose tissue composition (fatty acids quantification, sterols, steroids)
RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profile and cytokines)
RTqPCR analysis, western blot and immunohistochemical expression of markers of transformation into brown adipose tissue
in specific milieu, in vitro experimentation on skeletal muscular cells
measure: on ovarian cancer tumor samples
time frame: ovarian tumor biopsies realized during surgery
description: lipid composition (fatty acids quantification, sterols, steroids)
RT-qPCR quantification of molecules involved in lipid metabolism (synthesis, transport) and in inflammation (immune profil and cytokines)
culture of tumour cells to evaluate resistance to chemotherapy (platinum)
measure: on computerized tomography
time frame: 1 day of abdominal CT scan imaging procedure performed at diagnosis
description: assessment of body composition (fat and muscle compartments)
arm group label: Case group
arm group type: Experimental
description: women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples
arm group label: Control group
arm group type: Other
description: women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples
intervention type: Other
intervention name: Samples
description: Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample
arm group label: Case group
arm group label: Control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lobna OULDAMER, MD, PhD
role: Principal Investigator
affiliation: University Teaching Hospital of Tours
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Endometrial Neoplasms
mesh term: Body Weight
mesh term: Weight Loss
sharing ipd: No