SarcopeniaMyomachiaNCT06475118
Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma
A study testing Dynamometry measurement, myokine dosing, sarcopenia calculation in people with Sarcopenia and Hepatocellular Carcinoma, run by CHU de Reims at 1 site in France.
Trial summary
It is known that some substances present in the blood, called 'myokines,' influence muscle loss. Some may accelerate this loss, while others may prevent it. Inflammatory substances in the blood can also contribute to muscle loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Hepatocellular Carcinoma
- What is being tested?
- Dynamometry measurement, myokine dosing, sarcopenia calculation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2024to 22 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of HCC made by radiology and/or histopathology according to EASL criteria, regardless of the degree of hepatic fibrosis (METAVIR F0-F4)
- Availability of a pre-therapeutic three-phase contrast-enhanced abdominal-pelvic CT scan.
- Non-inclusion criteria:
- Presence of an active cancer other than HCC
- Uncontrolled HIV infection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Elia GIGANTE, 03 26 78 33 43 ext. 0033, egigante@chu-reims.fr
About this study
It is known that some substances present in the blood, called 'myokines,' influence muscle loss. Some may accelerate this loss, while others may prevent it. Inflammatory substances in the blood can also contribute to muscle loss. Sarcopenia is assessed by an imaging technique called 'Skeletal Muscle Mass Index (SMI)' to measure muscle mass. This analysis can be done from radiological examinations. Sarcopenia has a serious impact on patients with hepatocellular carcinoma. It increases the risk of death, cancer recurrence, and decreases the response to treatments. Therefore, the investigators want to determine if blood tests for myokines obtained by simple blood draw can improve the assessment of sarcopenia in this specific setting.
Read the detailed description
Background:
Sarcopenia, which is a reduction of muscle mass and function, frequently occurs from the age of 40 and is exacerbated by diseases such as cirrhosis, chronic inflammation, and cancer. It is well established that sarcopenia impairs quality of life and promotes the occurrence of complications. Myostatin, a muscle hormone (myokine), contributes to sarcopenia by promoting muscle degradation. Conversely, follistatin, an antagonist of myostatin, may play a role in maintaining muscle mass and protein synthesis. Irisin, another myokine, can protect against muscle atrophy and improve metabolism. Inflammatory cytokines like TNF-α and IL-6 can also contribute to sarcopenia by promoting muscle degradation. To evaluate sarcopenia in patients with cirrhosis and cancer, the most commonly used method is the calculation of the Skeletal Muscle Index (SMI) at the third lumbar vertebra (L3 SMI: Total Muscle Surface at L3 in cm²/ Height in m²). Other methods can also be used, but are susceptible to being influenced by water retention, particularly in cirrhotic patients. In patients with cirrhosis, sarcopenia negatively impacts quality of life and is associated with an increased risk of serious complications. In patients with hepatocellular carcinoma (HCC), it increases mortality, tumor recurrence, and reduces the response to treatments. Thus, its assessment and management are essential to improve the quality of life and prognosis of these patients. The validation of biological diagnostic criteria for sarcopenia would facilitate diagnosis and ensure follow-up without resorting to repetitive imaging.
Materials and Methods:
Type of study: Prospective validation study of a diagnostic method
Judgment criteria:
- Serum concentrations of myostatin, follistatin, and irisin
- Muscle surface calculated at L3 and parameterized according to height (L3 SMI)
- Muscle strength assessed by dynamometry
Investigation plan:
- Screening of Patient after discussion in Multidisciplinary Liver Cancer Board
- Proposal of the study during the announcement consultation after RCP.
- Blood sampling during standard pre-therapeutic care and dynamometry measurement
- Retrieval of scanographic imaging and calculation of the L3 SMI index
- Blood dosages of myokines
- Statistical analyses
Schedule:
- April 2024-July 2024: CPP evaluation
- August 2024-July 2025: Inclusion period.
- August 2024-July 2025: Radiological analyses (in parallel with the inclusions). Selection of available imagery, extraction of key images. Analysis of muscle mass and calculation of the L3 SMI index.
- August 2024-July 2025: Biological analyses (in parallel with the radiological analyses). Measurement of blood concentrations of myokines.
- August 2025-April 2026: Statistical analyses and article writing.
Expected Results and Prospects:
The current priority og investigators is to validate rapid and effective serum markers to facilitate the early diagnosis and clinical follow-up of sarcopenia in patients with hepatocellular carcinoma. In the long term, the goal is to implement early interventions aimed at mitigating the effects of sarcopenia. These serum markers could improve the management of liver diseases and cancers as key prognostic factors. The results of this study will also contribute to a better pathophysiological understanding of sarcopenia in these patients.
- Conditions
- Sarcopenia, Hepatocellular Carcinoma
- Being tested
- Dynamometry measurement, myokine dosing, sarcopenia calculation
- Keywords
- Sarcopenia, Hepatocellular Carcinoma, myokines
- Medical subject headings
- Sarcopenia, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamometry measurement, myokine dosing, sarcopenia calculationOther
Blood sampling during standard pre-therapeutic care (at the same time with a standard blood testing) and dynamometry measurement. Retrieval of scanographic imaging and calculation of the L3 SMI index
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatocellular carcinoma | Experimental | Not described Receives: Other: Dynamometry measurement, myokine dosing, sarcopenia calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique.
Analysis of correlation between serum myokines measured in patients with HCC and muscle mass index assessed by standard scanographic technique
Measured: Day 1
Secondary outcomes (4)
Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 50 cm2/m2 in men
Analysis of correlation between serum myokines thresholds in patients with HCC and sarcopenia defined by an L3 SMI < 50 cm^2/m^2 in men
Measured: Day 1
Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 39 cm2/m2 in women
Analysis of correlation between serum myokines thresholds in patients with HCC and sarcopenia defined by an L3 SMI < 39 cm^2/m^2 in women
Measured: Day 1
Determine if serum myokines measured in patients with HCC are correlated with muscle strength assessed by dynamometry
Analysis of correlation between serum myokines measured in patients with HCC and Muscle strength assessed by dynamometry
Measured: Day 1
Determine if inflammatory cytokines (IL6, TNFα) measured in patients with HCC are correlated with muscle mass index assessed by the standard scanographic technique
Analysis of correlation between inflammatory cytokines (IL6, TNFα) measured in patients with HCC and muscle mass index assessed by the standard scanographic technique
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start22 Nov 2024
- Primary completion22 Nov 2025 (estimated)
- Study completion22 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475118
- Sponsor's protocol ID
- PA24055
- Acronym
- Myomachia
- Status last verified
- Nov 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06475118
- Acronym / sponsor ID
- Myomachia / PA24055
- Conditions
- Sarcopenia, Hepatocellular Carcinoma
- Keywords
- Sarcopenia, Hepatocellular Carcinoma, myokines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 22 Nov 2025 (estimated)
- Study completion
- 22 May 2026 (estimated)
- First posted
- 26 Jun 2024 (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.
It is known that some substances present in the blood, called 'myokines,' influence muscle loss. Some may accelerate this loss, while others may prevent it. Inflammatory substances in the blood can also contribute to muscle loss. Sarcopenia is assessed by an imaging technique called 'Skeletal Muscle Mass Index (SMI)' to measure muscle mass. This analysis can be done from radiological examinations. Sarcopenia has a serious impact on patients with hepatocellular carcinoma. It increases the risk of death, cancer recurrence, and decreases the response to treatments. Therefore, the investigators want to determine if blood tests for myokines obtained by simple blood draw can improve the assessment of sarcopenia in this specific setting.
Detailed description
Background:
Sarcopenia, which is a reduction of muscle mass and function, frequently occurs from the age of 40 and is exacerbated by diseases such as cirrhosis, chronic inflammation, and cancer. It is well established that sarcopenia impairs quality of life and promotes the occurrence of complications. Myostatin, a muscle hormone (myokine), contributes to sarcopenia by promoting muscle degradation. Conversely, follistatin, an antagonist of myostatin, may play a role in maintaining muscle mass and protein synthesis. Irisin, another myokine, can protect against muscle atrophy and improve metabolism. Inflammatory cytokines like TNF-α and IL-6 can also contribute to sarcopenia by promoting muscle degradation. To evaluate sarcopenia in patients with cirrhosis and cancer, the most commonly used method is the calculation of the Skeletal Muscle Index (SMI) at the third lumbar vertebra (L3 SMI: Total Muscle Surface at L3 in cm²/ Height in m²). Other methods can also be used, but are susceptible to being influenced by water retention, particularly in cirrhotic patients. In patients with cirrhosis, sarcopenia negatively impacts quality of life and is associated with an increased risk of serious complications. In patients with hepatocellular carcinoma (HCC), it increases mortality, tumor recurrence, and reduces the response to treatments. Thus, its assessment and management are essential to improve the quality of life and prognosis of these patients. The validation of biological diagnostic criteria for sarcopenia would facilitate diagnosis and ensure follow-up without resorting to repetitive imaging.
Materials and Methods:
Type of study: Prospective validation study of a diagnostic method
Judgment criteria:
- Serum concentrations of myostatin, follistatin, and irisin
- Muscle surface calculated at L3 and parameterized according to height (L3 SMI)
- Muscle strength assessed by dynamometry
Investigation plan:
- Screening of Patient after discussion in Multidisciplinary Liver Cancer Board
- Proposal of the study during the announcement consultation after RCP.
- Blood sampling during standard pre-therapeutic care and dynamometry measurement
- Retrieval of scanographic imaging and calculation of the L3 SMI index
- Blood dosages of myokines
- Statistical analyses
Schedule:
- April 2024-July 2024: CPP evaluation
- August 2024-July 2025: Inclusion period.
- August 2024-July 2025: Radiological analyses (in parallel with the inclusions). Selection of available imagery, extraction of key images. Analysis of muscle mass and calculation of the L3 SMI index.
- August 2024-July 2025: Biological analyses (in parallel with the radiological analyses). Measurement of blood concentrations of myokines.
- August 2025-April 2026: Statistical analyses and article writing.
Expected Results and Prospects:
The current priority og investigators is to validate rapid and effective serum markers to facilitate the early diagnosis and clinical follow-up of sarcopenia in patients with hepatocellular carcinoma. In the long term, the goal is to implement early interventions aimed at mitigating the effects of sarcopenia. These serum markers could improve the management of liver diseases and cancers as key prognostic factors. The results of this study will also contribute to a better pathophysiological understanding of sarcopenia in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatocellular carcinoma | Experimental | Other: Dynamometry measurement, myokine dosing, sarcopenia calculation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New diagnosis of HCC made by radiology and/or histopathology according to EASL criteria, regardless of the degree of hepatic fibrosis (METAVIR F0-F4)
- Availability of a pre-therapeutic three-phase contrast-enhanced abdominal-pelvic CT scan.
- Presence of an active cancer other than HCC
- Uncontrolled HIV infection.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Dynamometry measurement, myokine dosing, sarcopenia calculationBlood sampling during standard pre-therapeutic care (at the same time with a standard blood testing) and dynamometry measurement. Retrieval of scanographic imaging and calculation of the L3 SMI index | Other | Patients with hepatocellular carcinoma |
Primary outcome
Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique.
Time frame: Day 1
Analysis of correlation between serum myokines measured in patients with HCC and muscle mass index assessed by standard scanographic technique
4 secondary outcomes
Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 50 cm2/m2 in men
Time frame: Day 1
Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 39 cm2/m2 in women
Time frame: Day 1
Determine if serum myokines measured in patients with HCC are correlated with muscle strength assessed by dynamometry
Time frame: Day 1
Determine if inflammatory cytokines (IL6, TNFα) measured in patients with HCC are correlated with muscle mass index assessed by the standard scanographic technique
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamometry measurement, myokine dosing, sarcopenia calculation in people with Sarcopenia and Hepatocellular Carcinoma, run by CHU de Reims 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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elia GIGANTE (03 26 78 33 43 ext. 0033, egigante@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique. (time frame: Day 1). 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 26 Nov 2024.