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

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy (Other)

Overall Status

Completed

CT.gov ID

NCT03042442

Collaborator

(none)

114

Enrollment

Location

20.9

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer, Adult Cachexia Pain Diabetes Mellitus	Diagnostic Test: Point-of care biomarkers Other: Clinical, venous blood samples, pancreatic tissue Other: Follow-up

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

Actual Enrollment :

114 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Diagnostic Test: Point-of care biomarkers

Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC

Other: Clinical, venous blood samples, pancreatic tissue

Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.

Other: Follow-up

Participants will be assessed (by telephone) over a period of 2 years

health patients (controls)

Health patients

Diagnostic Test: Point-of care biomarkers

Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC

Other: Clinical, venous blood samples, pancreatic tissue

Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.

Other: Follow-up

Participants will be assessed (by telephone) over a period of 2 years

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]