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NCT Number: NCT05833321

Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer

Prospective monocentric study, non-randomized of the detection of sarcopenia in clinical practice in patients with ovarian or endometrial cancer requiring systemic oncological treatment.

main question : Identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria.

Data collection will be done at 6 months, 12 months after the date of inclusion.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Metropole Savoie

Chambéry, Savoie, 73011, France

Location status: Recruiting

Location contact

fillon aurélie

PRINCIPAL_INVESTIGATOR

jego florence, ARC

CONTACT

0479965813

marques nathalie

SUB_INVESTIGATOR

About this study

Primary objective:Identify the criteria correlated to the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria

Main judgment criteria : Comparison between the groups of patients with sarcopenia (Morphometric measurement of the musculoskeletal surface index <39cm²/m² in L3 cross section) and without sarcopenia of the different evaluation criteria:

  • Impedancemetry values:: muscle mass index in kg/m2 (IMS), fat-free mass in kg/m2 and metabolic activity index (phase angle)
  • Percentage of weight loss
  • BMI < 18.5 kg/m2
  • Quantified reduction in muscle mass and/or function for patients < 70 years old
  • Quantified reduction in muscle mass and function for patients > 70 years old
  • Physical tests: walking speed and "hand grip" dynamometer secondary objectives:- Proposal of a composite score for the detection of sarcopenia usable in clinical routine
  • Evaluation of nutritional intake
  • Evaluation of the severity of undernutrition
  • Verification of a correlation between the sarcopenia indices of ovarian and endometrial cancer
  • Evaluate tolerance profiles to systemic treatments with regard to sarcopenia figures
  • Assess the relationship between PFS, OS and sarcopenia index in cancer diagnosis secondary judgment criteria :
  • Statistical analysis of sarcopenia and undernutrition data
  • Quantification of ingestates (SEFI scale) +/- intake of oral nutritional supplement
  • Serological tests: NFS, CRP and Albuminemia
  • Comparison of sarcopenia index figures between ovarian and endometrial cancer
  • Collection of the grades of toxicities and adverse events to systemic treatments in parallel with the measurement of sarcopenia.
  • Correlation between progression-free survival, death and sarcopenia index at cancer diagnosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients at least 18 years old
  • Patient presenting with a diagnosis of cancer of ovarian origin with an indication for chemotherapy
  • Patient with a diagnosis of endometrial cancer with an indication for chemotherapy
  • Patient with no diagnosis of other types of cancer in the previous five years
  • Collection of consent
  • Patient affiliated to a Social Security scheme

Exclusion criteria

  • Patient with cancer of ovarian origin not requiring chemotherapy treatment
  • Patient with endometrial cancer not requiring chemotherapy treatment
  • Discovery of an intercurrent cancer other than skin or cervix cancers.
  • Patient wearing a Pace maker

Treatment and study plan

Sarcopenia diagnostic test

Diagnostic Test

measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire

Primary outcomes

  1. clinical screening for sarcopenia

    Time frame: 36 month

    Identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria.

  2. Proposal of a composite score for the detection of sarcopenia usable in clinical routine

    Time frame: 36 month

    Statistical analysis of sarcopenia and undernutrition data

Study contacts

Contact information is provided by the study sponsor or research team.

jego florence

CONTACT

[email protected]

0479965813

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Official study title

Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment

Acronym: SARCO-GYN

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 27, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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