Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with pancreatic cancer | Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis, before any therapeutic intervention. |
| |
| health patients (controls) | Health patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of care biomarkers | Diagnostic Test | Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with loss of > 5% body weight | Using the BMI at admission and BMI at 6 months after admission | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 12 Months |
| Evaluation of Quality of Life of participants (EORTC QLQ-C30 ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis, before any therapeutic intervention.
Subjects of the study group were at least 18 years old, with no previous history of any other cancer in the last 5 years. Written consent was given prior to entry into the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Livia Petrusel, MD, PhD | Iuliu Hatieganu University of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Institute of Gastroenterology and Hepatology | Cluj-Napoca | Cluj | 400192 | Romania |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Venous blood samples and pancreatic cancer tissue (from EUS FNA and surgery) will be collected from patients with pancreatic cancer adenocarcinoma at the time of diagnosis. The blood sample will be immediately prepared by centrifugation at 5000 × g for 5 min. The plasma samples were stored at -80 °C until use. Tissue will be embedded in paraffin.
Point-of-care bio-markers will be assessed by using western blot analyses and immunohistochemistry.
The participant will be explicitly asked for consent for storing the plasma sample.
| Clinical, venous blood samples, pancreatic tissue | Other | Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers. |
|
| Follow-up | Other | Participants will be assessed (by telephone) over a period of 2 years |
|
At baseline, throughout and at the end of the study using EORTC QLQ-C30 questionnaire |
| 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 | Change from baseline at 6 months |
| Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years | up to 2 years |
| ID | Term |
|---|---|
| C535836 | Pancreatic cancer, adult |
| D002100 | Cachexia |
| D010146 | Pain |
| D003920 | Diabetes Mellitus |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D009461 | Neurologic Manifestations |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
Not provided
Not provided