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Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer (SARCO-GYN)

Primary Purpose

Ovarian Neoplasms, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sarcopenia diagnostic test
Sponsored by
Centre Hospitalier Metropole Savoie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Metropole SavoieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventionnal

Arm Description

"Hand Grip" Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire

Outcomes

Primary Outcome Measures

clinical screening for sarcopenia
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.
Proposal of a composite score for the detection of sarcopenia usable in clinical routine
Statistical analysis of sarcopenia and undernutrition data

Secondary Outcome Measures

Full Information

First Posted
April 17, 2023
Last Updated
June 29, 2023
Sponsor
Centre Hospitalier Metropole Savoie
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1. Study Identification

Unique Protocol Identification Number
NCT05833321
Brief Title
Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer
Acronym
SARCO-GYN
Official Title
Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Metropole Savoie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Sarcopenia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective non-randomized interventional study
Masking
None (Open Label)
Masking Description
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 Non-inclusion 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
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventionnal
Arm Type
Experimental
Arm Description
"Hand Grip" Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire
Intervention Type
Diagnostic Test
Intervention Name(s)
Sarcopenia diagnostic test
Intervention Description
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire
Primary Outcome Measure Information:
Title
clinical screening for sarcopenia
Description
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.
Time Frame
36 month
Title
Proposal of a composite score for the detection of sarcopenia usable in clinical routine
Description
Statistical analysis of sarcopenia and undernutrition data
Time Frame
36 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jego florence
Phone
0479965813
Email
florence.jego@ch-metropole-savoie.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fillon aurélie
Organizational Affiliation
Centre Hospitalier Metropole Savoie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Metropole Savoie
City
Chambéry
State/Province
Savoie
ZIP/Postal Code
73011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jego florence, ARC
Phone
0479965813
First Name & Middle Initial & Last Name & Degree
fillon aurélie
First Name & Middle Initial & Last Name & Degree
marques nathalie

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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