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Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss (METERMUS-IMC)

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ClinicalTrials.gov Identifier: NCT03027479
Recruitment Status : Unknown
Verified October 2017 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : January 23, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Inserm U1069 - Team Nutrition, Growth and Cancer
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Weight Loss Ovarian Carcinoma Endometrial Carcinoma Other: Samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


Arm Intervention/treatment
Experimental: Case group
women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples
Other: Samples
Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample

Control group
women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples
Other: Samples
Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample




Primary Outcome Measures :
  1. Measurement of muscle mitochondrial bioenergetics according to BMI [ Time Frame: muscle biopsy realized during surgery ]
    Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy


Secondary Outcome Measures :
  1. on muscle biopsy [ Time Frame: muscle biopsy realized during surgery ]
    • 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

  2. on white adipose tissue [ Time Frame: adipose tissue samples taken during surgery ]

    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

  3. on ovarian cancer tumor samples [ Time Frame: ovarian tumor biopsies realized during surgery ]
    • 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)

  4. on computerized tomography [ Time Frame: 1 day of abdominal CT scan imaging procedure performed at diagnosis ]
    assessment of body composition (fat and muscle compartments)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Case group selection criteria:

Inclusion Criteria:

  • Women aged 18 years old and more
  • Ovarian and/or endometrial cancer
  • weight loss related to cancer (weight loss > 5% weight in one month or 10% in 6 months)
  • Indication to therapeutic surgery
  • Women affiliated to social security scheme
  • Women who can understand French and able to sign Informed consent

Exclusion Criteria:

  • Unbalanced Diabetes
  • Chronic neuromuscular disorder
  • Any severe uncontrolled medical condition

Control group selection criteria:

Inclusion Criteria:

  • Women aged 18 years and more
  • Surgery Indication for a benign endometrial and/ or ovarian disease
  • Patient affiliated to social security scheme
  • Women who can understand French and able to sign Informed consent

Exclusion Criteria:

  • Unbalanced Diabetes
  • Chronic neuromuscular disorder
  • Any severe uncontrolled medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027479


Contacts
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Contact: Lobna OULDAMER, MD, PhD +33(0)2.47.47.47.41 l.ouldamer@chu-tours.fr
Contact: Stéphane SERVAIS, PhD +33(0)2.47.36.60.59 stephane.servais@univ-tours.fr

Locations
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France
Gynecology Department, University Teaching Hospital, Tours Recruiting
Tours, France, 37044
Contact: Lobna OULDAMER, MD, PhD    +33(0)2.47.47.47.41    l.ouldamer@chu-tours.fr   
Sponsors and Collaborators
University Hospital, Tours
Inserm U1069 - Team Nutrition, Growth and Cancer
Investigators
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Principal Investigator: Lobna OULDAMER, MD, PhD University Teaching Hospital of Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03027479     History of Changes
Other Study ID Numbers: PHAO16-LO/METERMUS-IMC
2016-A01323-48 ( Registry Identifier: IdRCB )
2016-R27 ( Other Identifier: CPP )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
weight loss
ovarian cancer
endometrial cancer
energy metabolism
Body mass index
obesity
muscle energy
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Body Weight
Weight Loss
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Signs and Symptoms
Body Weight Changes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female