Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy

Conditions
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Pancreatic Cancer, Adult, Cachexia, Pain, Diabetes Mellitus

Intervention / Treatment
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* Diagnostic Test: Point-of care biomarkers
* Other: Clinical, venous blood samples, pancreatic tissue
* Other: Follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with pancreatic cancer<br>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. | Diagnostic Test: Point-of care biomarkers<br>* Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC<br>Other: Clinical, venous blood samples, pancreatic tissue<br>* Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.<br>Other: Follow-up<br>* Participants will be assessed (by telephone) over a period of 2 years<br>|
| health patients (controls)<br>Health patients | Diagnostic Test: Point-of care biomarkers<br>* Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC<br>Other: Clinical, venous blood samples, pancreatic tissue<br>* Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.<br>Other: Follow-up<br>* Participants will be assessed (by telephone) over a period of 2 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 ) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, cachexia, perineural invasion, pancreatic cancer, diabetes