The Diagnostic and Predictive Value of Different Biomarkers in Pancreatic Juice and Blood in Patients with Pancreatic Cancer.
Recruiting
- Conditions
- pancreascarcinoma.Pancreatic cancer10017991
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 530
Inclusion Criteria
Patients with (suspected) pancreatic tumour, chronic pancreatitis and healthy
controls (non-pancreatic non-healthy) that undergo an endoscopic ultrasound or
ERCP.
The latter group is defined as all individuals undergoing endoscopic ultrasound
or ERCP for a non-pancreatic indication (e.g. choledocholithiasis), individuals
with a personal history with pancreatic disease (including pancreatic cysts,
pancreatitis or any other pancreas-related disease, post-surgery) or autoimmune
disease will not be included in this group. In addition, patients with a
history of malignancy could only be included if they have been treated
curatively >5 years ago.
Exclusion Criteria
Age < 18 years.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter: CtDNA levels in pancreatic juice and blood in relation to<br /><br>(progression-free) survival. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters (in patients undergoing EUS or ERCP for (suspected)<br /><br>PC)<br /><br>- CtDNA levels in pancreatic juice and blood.<br /><br>- CINdex in pancreatic juice and blood.<br /><br>- The cellular composition of pancreatic juice: number of cancer cells,<br /><br>clonality of the cancer cells, intracellular (single-cell) mutations (e.g.<br /><br>KRAS, CDKN2A, SMAD-4, TP53), the capability to grow organoids.<br /><br>- Molecular composition of pancreatic juice and blood: levels of pro- and<br /><br>anti-inflammatory molecules, levels and function of inhibitory and activating<br /><br>immune cells, levels of molecules related to fibrosis.<br /><br>- (Progression free) survival (assessed after 12 and 18 months) based on<br /><br>morphology on MRI and EUS.<br /><br>- Tumour size.<br /><br>- Presence of metastases.</p><br>