Comparison of Serum Myokine Dosages and Imaging Methods in the Evaluation of Sarcopenia in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Determine if serum myokines measured in patients with HCC are correlated with muscle mass index assessed by standard scanographic technique.
时间窗: Day 1
Analysis of correlation between serum myokines measured in patients with HCC and muscle mass index assessed by standard scanographic technique
次要结局
- Determine if inflammatory cytokines (IL6, TNFα) measured in patients with HCC are correlated with muscle mass index assessed by the standard scanographic technique(Day 1)
- Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 50 cm2/m2 in men(Day 1)
- Determine the serum myokine concentration threshold for the diagnosis of sarcopenia defined by an L3 SMI < 39 cm2/m2 in women(Day 1)
- Determine if serum myokines measured in patients with HCC are correlated with muscle strength assessed by dynamometry(Day 1)