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.
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.
Study Type
OBSERVATIONAL
Enrollment
114
Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
Participants will be assessed (by telephone) over a period of 2 years
Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Cluj, Romania
Rate of patients with loss of > 5% body weight
Using the BMI at admission and BMI at 6 months after admission
Time frame: up to 6 months
Number of participants with pain as main symptom and antialgic therapy
At baseline, throughout and at the end of the study as assessed by Visual Analogue Scale and type of antialgic treatment
Time frame: up to 12 Months
Evaluation of Quality of Life of participants (EORTC QLQ-C30 )
At baseline, throughout and at the end of the study using EORTC QLQ-C30 questionnaire
Time frame: Change from baseline at 12 months
Food intake assessment of participants using SNAQ questionnaire
At baseline, throughout and at the end of the study using SNAQ questionnaire
Time frame: Change from baseline at 6 months
Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years
Time frame: up to 2 years
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