The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Muscle gene expression
研究概览
简要总结
Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. To determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of great importance.
Objective: Main aim of the study is to investigate the differences in gene expression, body composition, muscle function and muscle metabolism in colon cancer patients compared to controls.
Study design: Observational study Study population: 40 colon cancer patients undergoing a tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5).
Main study parameters/endpoints: Primary study parameter will be gene expression (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary parameters will be body composition (determined in available CT scans and bio impedance analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies), biochemical markers (measured in blood/serum) and gene expression of fat biopsies.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators expect no additional risk for the subjects due to the proposed measurements. Biopsies will be taken during the planned operation and therefore is not expected to cause a significant increase in burden for the patient. All other measurements are non-invasive, observational measurements with no risk of any harmful side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CC patients:
- •In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria:
- •Diagnosed with primary colon cancer (30) or liver metastases due to colon cancer(10)
- •Eligible for a primary tumor or liver metastases resection procedure
- •Controls:
- •Eligible for an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5)
排除标准
- •CC patients:
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Having had chemotherapy or an operational procedure of the abdomen in the past 6 months
- •Suffering from malabsorption
- •Controls:
- •Having had treatment for previous or current tumors
结局指标
主要结局
Muscle gene expression
时间窗: Biopsy during surgery
Muscle gene expression measured by microarray in a muscle biopsy taken from the rectus abdominis
次要结局
- Muscle function(Before surgery)
- Adipose tissue gene expression(Biopsy during surgery)
- Cholesterol levels in the blood(Blood taken prior to surgery)
- Body composition(Before surgery)
- Muscle protein metabolism(Biopsy during surgery)
- Cytokine parameters in the blood(Blood taken prior to surgery)
- Micro-nutrient parameters in the blood(Blood taken prior to surgery)