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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
* No signs of local recurrence or metastatic disease at a CT scan 4 months after the operation
Exclusion Criteria:
* 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
Primary outcome measure(s)
Sub-study 1 ctDNA — 36 months Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.
Sub-study 1 eccDNA — 36 months Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.
Sub-study 2 ctDNA DFS — 3 years from surgery for PDAC Number of patients with recurrence assessed by ctDNA
Sub-study 2 ctDNA OS — 3 years from surgery for PDAC Overall survival of patients in arm A compared with patients in Arm B
Sub-study 2 eccDNA — 3 years from surgery for PDAC Number of patients with recurrence assessed by eccDNA
Trial sites (5)
Facility
City
Region
Status
Aalborg Universitetshospital
Aalborg
Denmark
Recruiting
Aarhus Universitetshospital
Aarhus
Denmark
Recruiting
Copenhagen University Hospital - Rigshospitalet
Copenhagen
Denmark
Recruiting
Copenhagen University Hospital - Herlev and Gentofte
Herlev
Denmark
Recruiting
Odense Universitetshospital
Odense
Denmark
Recruiting
More Copenhagen University Hospital at Herlev trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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