Cachexia, Diabetes Mellitus, Pain, Pancreatic Cancer, Adult
Conditions
Keywords
pancreatic cancer, cachexia, perineural invasion, pain, diabetes
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTPoint-of care biomarkers
Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
OTHERClinical, venous blood samples, pancreatic tissue
Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
OTHERFollow-up
Participants will be assessed (by telephone) over a period of 2 years
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Inclusion criteria
1. Age over 18 years old 2. EUS or surgery biopsy confirming the diagnosis of adenocarcinoma 3. Informed consent
Exclusion criteria
1. obvious malabsorption 2. artificial nutrition 3. hyperthyroidism 4. major depression 5. other causes of malnutrition 6. refusing to enter the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with loss of > 5% body weight | up to 6 months | Using the BMI at admission and BMI at 6 months after admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with pain as main symptom and antialgic therapy | up to 12 Months | At baseline, throughout and at the end of the study as assessed by Visual Analogue Scale and type of antialgic treatment |
| Evaluation of Quality of Life of participants (EORTC QLQ-C30 ) | Change from baseline at 12 months | At baseline, throughout and at the end of the study using EORTC QLQ-C30 questionnaire |
| Food intake assessment of participants using SNAQ questionnaire | Change from baseline at 6 months | At baseline, throughout and at the end of the study using SNAQ questionnaire |
| Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years | up to 2 years | — |
Countries
Romania
Outcome results
None listed