An observational study in Pancreatic Cancer, Adult, Cachexia and Pain, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Completed at 1 site in Romania. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Observational
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 114 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Iuliu Hatieganu University of Medicine and Pharmacy is the lead sponsor of 53 studies on the registry; 13 are open to participants now.
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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.
Exclusion Criteria:
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 · Other: Clinical, venous blood samples, pancreatic tissue · Other: Follow-up
Health patients
Diagnostic Test: Point-of care biomarkers · Other: Clinical, venous blood samples, pancreatic tissue · Other: Follow-up
Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
Participants will be assessed (by telephone) over a period of 2 years
Rate of patients with loss of > 5% body weight
Using the BMI at admission and BMI at 6 months after admission
Time frame: up to 6 months
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
Time frame: 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
Time frame: 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
Time frame: Change from baseline at 6 months
Assessing the survival rate by phone-calls follow-up every 6 months, up to 2 years
Time frame: up to 2 years
Plan to share: No
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Iuliu Hatieganu University of Medicine and Pharmacy