Ignite Creation Date:
2024-07-17 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475118
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-20
Brief Title:
Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Myomachia
Brief 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 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
1 Screening of Patient after discussion in Multidisciplinary Liver Cancer Board
2 Proposal of the study during the announcement consultation after RCP
3 Blood sampling during standard pre-therapeutic care and dynamometry measurement
4 Retrieval of scanographic imaging and calculation of the L3 SMI index
5 Blood dosages of myokines
6 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
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
1 Screening of Patient after discussion in Multidisciplinary Liver Cancer Board
2 Proposal of the study during the announcement consultation after RCP
3 Blood sampling during standard pre-therapeutic care and dynamometry measurement
4 Retrieval of scanographic imaging and calculation of the L3 SMI index
5 Blood dosages of myokines
6 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 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