Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Rate of patients with loss of > 5% body weight
研究概览
简要总结
The purpose of this study is to determine the interrelationship between cachexia, neural invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.
详细描述
In this study, the investigators will prospectively evaluate pancreatic adenocarcinoma patients with or without cachexia, perineural invasion and diabetes.
Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis and blood samples are drawn.
Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with benign pancreatic disorders and healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.
Furthermore, the investigators propose to identify the prognostic role of these biomarkers in the development of metastasis and survival in patients with adenocarcinoma, with and without diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic treatment) and investigating the role of invasion neural in the appearance of cachexia in patients with pancreatic adenocarcinoma.
Follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following data: survival, date of decease and its direct cause, the presence of tumor recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
- •Informed consent
排除标准
- •obvious malabsorption
- •artificial nutrition
- •hyperthyroidism
- •major depression
- •other causes of malnutrition
- •refusing to enter the study
结局指标
主要结局
Rate of patients with loss of > 5% body weight
时间窗: up to 6 months
Using the BMI at admission and BMI at 6 months after admission
次要结局
- Evaluation of Quality of Life of participants (EORTC QLQ-C30 )(Change from baseline at 12 months)
- Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years(up to 2 years)
- Number of participants with pain as main symptom and antialgic therapy(up to 12 Months)
- Food intake assessment of participants using SNAQ questionnaire(Change from baseline at 6 months)
研究者
Livia Petrusel
MD, PhD Student
Iuliu Hatieganu University of Medicine and Pharmacy