NCT03027479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

January 19, 2017

Last Update Submit

December 15, 2025

Conditions

Weight LossOvarian CarcinomaEndometrial Carcinoma

Keywords

weight lossovarian cancerendometrial cancerenergy metabolismBody mass indexobesitymuscle energy

Outcome Measures

Primary Outcomes (1)

  • Measurement of muscle mitochondrial bioenergetics according to BMI

    Measurement of muscle mitochondrial bioenergetics by high resolution oxygraphy

    muscle biopsy realized during surgery

Secondary Outcomes (4)

  • on muscle biopsy

    muscle biopsy realized during surgery

  • on white adipose tissue

    adipose tissue samples taken during surgery

  • on ovarian cancer tumor samples

    ovarian tumor biopsies realized during surgery

  • on computerized tomography

    1 day of abdominal CT scan imaging procedure performed at diagnosis

Study Arms (2)

Case group

EXPERIMENTAL

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

Other: Samples

Control group

OTHER

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

Other: Samples

Interventions

SamplesOTHER

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

Case groupControl group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unbalanced Diabetes
  • Chronic neuromuscular disorder
  • Any severe uncontrolled medical condition
  • Control group selection 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
  • Unbalanced Diabetes
  • Chronic neuromuscular disorder
  • Any severe uncontrolled medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecology Department, University Teaching Hospital, Tours

Tours, 37044, France

Location

Related Publications (1)

  • Salaun H, Poisson M, Dolly A, Arbion F, Servais S, Dumas JF, Goupille C, Ouldamer L. Total Polyunsaturated Fatty Acid Level in Abdominal Adipose Tissue as an Independent Predictor of Recurrence-Free Survival in Women with Ovarian Cancer. Int J Mol Sci. 2023 Jan 16;24(2):1768. doi: 10.3390/ijms24021768.

    PMID: 36675280RESULT

MeSH Terms

Conditions

Weight LossOvarian NeoplasmsEndometrial NeoplasmsObesity

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lobna OULDAMER, MD, PhD

    University Teaching Hospital of Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 23, 2017

Study Start

March 1, 2017

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)