Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Rate of patients with loss of > 5% body weight
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age over 18 years old
- •EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
- •Informed consent
Exclusion Criteria
- •obvious malabsorption
- •artificial nutrition
- •hyperthyroidism
- •major depression
- •other causes of malnutrition
- •refusing to enter the study
Outcomes
Primary Outcomes
Rate of patients with loss of > 5% body weight
Time Frame: up to 6 months
Using the BMI at admission and BMI at 6 months after admission
Secondary Outcomes
- 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)
Investigators
Livia Petrusel
MD, PhD Student
Iuliu Hatieganu University of Medicine and Pharmacy