Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Correlation between skeletal muscle and degree myostatin
研究概览
简要总结
Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men aged 40-
- •Diagnosis for cancer of digestive system requiring surgery with neoadjuvant treatment or not.
- •Signature of consent
- •Affiliate or beneficiary of social security
排除标准
- •Administration of corticosteroids.
- •Thyroid disease treated.
- •Severe chronic pathology during treatment (neuro-muscular pathologies, renal insufficiency requiring dialysis, COPD under continuous oxygen therapy).
- •Psychological, familial, social or geographical conditions that could affect the participation of the subject throughout the duration of the protocol.
- •BMI> 30 due to the difficulty of interpretation of BMI variations in obese patients
结局指标
主要结局
Correlation between skeletal muscle and degree myostatin
时间窗: Day 1
Evaluate correlation between skeletal muscle force/index and degree myostatin. Skeletal muscle force/index will be determinated by skeletal muscle force/index results. Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.
次要结局
- Correlation between skeletal muscle force and index before resection surgery(Baseline from 7 months)
- Correlation between level of myostatin muscular expression and degree myostatin(Month 2)
- Correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery(Month 7)
- Analysis level of myostatin muscular expression and blood samples results(Month 2)