## Protocol Section
### Identification Module
**NCT ID:** NCT03027479

**Acronym:** METERMUS-IMC

**Brief Title:** Skeletal Muscle Energy Metabolism in Women With Weight Loss and Ovarian and/or Endometrial Cancer With Weight Loss

**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

#### Organization Study ID Info
**ID:** PHAO16-LO/METERMUS-IMC
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Tours
#### Secondary ID Infos
**Domain:** IdRCB
**ID:** 2016-A01323-48
**Type:** REGISTRY
**Domain:** CPP
**ID:** 2016-R27
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2019-07-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-06

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07-16

**Type:** ACTUAL

#### Start Date
**Date:** 2017-03-01

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2017-01-23
**Type:** ESTIMATED
**Study First Submit Date:** 2017-01-19
**Study First Submit QC Date:** 2017-01-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Inserm U1069 - Team Nutrition, Growth and Cancer

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Tours

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Weight Loss

- Ovarian Carcinoma

- Endometrial Carcinoma

**Keywords:**

- weight loss

- ovarian cancer

- endometrial cancer

- energy metabolism

- Body mass index

- obesity

- muscle energy

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 70

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** women with ovarian and/or endometrial cancer and weight loss will have muscle, adipose tissue, ovarian tumor and blood samples

**Intervention Names:**

- Other: Samples

**Label:** Case group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** women scheduled for an intervention for benign ovarian/ endometrial disease and no weight loss will have muscle, adipose tissue and blood samples

**Intervention Names:**

- Other: Samples

**Label:** Control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Case group

- Control group

**Description:** Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample

**Name:** Samples

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

**Measure:** Measurement of muscle mitochondrial bioenergetics according to BMI

**Time Frame:** muscle biopsy realized during surgery

#### Secondary Outcomes

**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 muscle biopsy

**Time Frame:** muscle biopsy realized 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 white adipose tissue

**Time Frame:** adipose tissue samples taken 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 ovarian cancer tumor samples

**Time Frame:** ovarian tumor biopsies realized during surgery

**Description:** assessment of body composition (fat and muscle compartments)

**Measure:** on computerized tomography

**Time Frame:** 1 day of abdominal CT scan imaging procedure performed at diagnosis

### Eligibility Module

**Eligibility 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tours

**Country:** France

**Facility:** Gynecology Department, University Teaching Hospital, Tours

**Zip:** 37044

#### Overall Officials

**Official 1:**

**Affiliation:** University Teaching Hospital of Tours

**Name:** Lobna OULDAMER, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000001836

- Term: Body Weight Changes

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Weight

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M19235

- Name: Endometrial Neoplasms

- Relevance: HIGH

- As Found: Endometrial Cancer

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: LOW

- As Found: Unknown

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000016889

- Term: Endometrial Neoplasms

- ID: D000001835

- Term: Body Weight

- ID: D000015431

- Term: Weight Loss

### Misc Info Module

- Version Holder: 2024-05-24
