The Diagnostic and Predictive Value of Different Biomarkers in Pancreatic Juice and Blood in Patients with Pancreatic Cancer.

The Diagnostic and Predictive Value of Different Biomarkers in Pancreatic Juice and Blood in Patients with Pancreatic Cancer. - KRAS mutation as a diagnostic biomarker.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54838

Enrollment

530

Registered

2018-10-23

Start date

2018-10-30

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreascarcinoma. Pancreatic cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
Main study parameter: CtDNA levels in pancreatic juice and blood in relation to (progression-free) survival.	—

Secondary

Measure	Time frame
Secondary study parameters (in patients undergoing EUS or ERCP for (suspected) PC) - CtDNA levels in pancreatic juice and blood. - CINdex in pancreatic juice and blood. - The cellular composition of pancreatic juice: number of cancer cells, clonality of the cancer cells, intracellular (single-cell) mutations (e.g. KRAS, CDKN2A, SMAD-4, TP53), the capability to grow organoids. - Molecular composition of pancreatic juice and blood: levels of pro- and anti-inflammatory molecules, levels and function of inhibitory and activating immune cells, levels of molecules related to fibrosis. - (Progression free) survival (assessed after 12 and 18 months) based on morphology on MRI and EUS. - Tumour size. - Presence of metastases.	—

Measure

Time frame

Secondary study parameters (in patients undergoing EUS or ERCP for (suspected) PC) - CtDNA levels in pancreatic juice and blood. - CINdex in pancreatic juice and blood. - The cellular composition of pancreatic juice: number of cancer cells, clonality of the cancer cells, intracellular (single-cell) mutations (e.g. KRAS, CDKN2A, SMAD-4, TP53), the capability to grow organoids. - Molecular composition of pancreatic juice and blood: levels of pro- and anti-inflammatory molecules, levels and function of inhibitory and activating immune cells, levels of molecules related to fibrosis. - (Progression free) survival (assessed after 12 and 18 months) based on morphology on MRI and EUS. - Tumour size. - Presence of metastases.

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Countries

Netherlands

Outcome results