The goal of this clinical trial is to investigate if plasma ctDNA and eccDNA before resection for suspicion of pancreatic ductal adenocarcinoma (PDAC) can predict early recurrence and overall survival, and to investigate if plasma ctDNA combined with CT scan and endoscopic ultrasound surveillance increases the median overall survival compared with standard-of-care surveillance.
Sub-study 1: Suspicion of PDAC tumor stage I-III, scheduled for pancreatic resection, with or without preoperative neoadjuvant chemotherapy.
Sub-study 2: .
PDAC tumor stage I-III
Has received intended curative resection (R0/R1) of PDAC
Other cancers (excluding skin cancer other than melanoma) later than 3 years before inclusion
Patients who are unlikely to comply with the protocol, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study
Parallel
ctDNA
Diagnostic testctDNA guided surveillance
Sub-study 1 ctDNA
Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.
Sub-study 1 eccDNA
Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.
Sub-study 2 ctDNA DFS
Number of patients with recurrence assessed by ctDNA
Sub-study 2 ctDNA OS
Overall survival of patients in arm A compared with patients in Arm B
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Copenhagen University Hospital at Herlev
Lead sponsor
Aarhus University Hospital
Collaborator
University of Copenhagen
Collaborator
Odense University Hospital
Collaborator
