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

NCT05833321 | Recruiting

• 1 other identifier: CHMS22005
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms; Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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.

  36 month

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

  Statistical analysis of sarcopenia and undernutrition data

  36 month

Study Arms (1)

Interventionnal

EXPERIMENTAL

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

Diagnostic Test: Sarcopenia diagnostic test

Interventions

Sarcopenia diagnostic test DIAGNOSTIC_TEST

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

Interventionnal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

Centre Hospitalier Metropole Savoie

Chambéry, Savoie, 73011, France

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• fillon aurélie

  Centre Hospitalier Metropole Savoie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jego florence

CONTACT

0479965813; florence.jego@ch-metropole-savoie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective non-randomized interventional study

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: November 20, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)