Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05833321
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-04-17
Brief Title:
Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer
Sponsor:
Centre Hospitalier Metropole Savoie
Organization:
Centre Hospitalier Metropole Savoie
Study Overview
Official Title:
Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SARCO-GYN
Brief Summary:
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
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
Detailed Description:
Primary objectiveIdentify 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 39cm²m² in L3 cross section and without sarcopenia of the different evaluation criteria
Impedancemetry values muscle mass index in kgm2 IMS fat-free mass in kgm2 and metabolic activity index phase angle
Percentage of weight loss
BMI 185 kgm2
Quantified reduction in muscle mass andor 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
Main judgment criteria Comparison between the groups of patients with sarcopenia Morphometric measurement of the musculoskeletal surface index 39cm²m² in L3 cross section and without sarcopenia of the different evaluation criteria
Impedancemetry values muscle mass index in kgm2 IMS fat-free mass in kgm2 and metabolic activity index phase angle
Percentage of weight loss
BMI 185 kgm2
Quantified reduction in muscle mass andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None