Ovarian NeoplasmsSARCO-GYNNCT05833321
Prospective Study of Detection of Sarcopenia in Clinical Practice for Patient With Ovarian or Endometrial Cancer
A study testing Sarcopenia diagnostic test in people with Ovarian Neoplasms and Sarcopenia, run by Centre Hospitalier Metropole Savoie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Sarcopenia
- What is being tested?
- Sarcopenia diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
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.
Read the 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
- Conditions
- Ovarian Neoplasms, Sarcopenia
- Being tested
- Sarcopenia diagnostic test
- Medical subject headings
- Ovarian Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia diagnostic testDiagnostic test
measurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Interventionnal | Experimental | "Hand Grip" Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire Receives: Diagnostic Test: Sarcopenia diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 month
Proposal of a composite score for the detection of sarcopenia usable in clinical routine
Statistical analysis of sarcopenia and undernutrition data
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start20 Nov 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Why it stopped: recruitement failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective non-randomized interventional study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fillon aurélie, Principal investigator, Centre Hospitalier Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833321
- Sponsor's protocol ID
- 2022-A01562-41
- Acronym
- SARCO-GYN
- Status last verified
- Dec 2023
- First submitted
- 17 Apr 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment
- ClinicalTrials.gov ID
- NCT05833321
- Acronym / sponsor ID
- SARCO-GYN / 2022-A01562-41
- Conditions
- Ovarian Neoplasms, Sarcopenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitement failure
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective non-randomized interventional study
| Arm | Type | Receives |
|---|---|---|
| Interventionnal | Experimental | Diagnostic Test: Sarcopenia diagnostic test"Hand Grip" Dynamometer Walk test SEFI Nutritional Intake Assessment Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarcopenia diagnostic testmeasurement of impedance and physical tests ("hand grip" dynamometer, walking test), SEFI nutritional intake questionnaire | Diagnostic test | Interventionnal |
Primary outcome
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.
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
Results and safety
The study was stopped early (reason given: recruitement failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Ovarian Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fillon aurélie principal investigator
Centre Hospitalier Metropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sarcopenia diagnostic test in people with Ovarian Neoplasms and Sarcopenia, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitement failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical screening for sarcopenia (time frame: 36 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.