Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer
Recruiting · NCT05788744 · Interventional (participants receive a specific treatment) · Lead sponsor: Copenhagen University Hospital at Herlev
View the official record on ClinicalTrials.gov →Interventions studied
ctDNA
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
5 locations listed.
- Aalborg Universitetshospital - Aalborg, Denmark
- Aarhus Universitetshospital - Aarhus, Denmark
- Copenhagen University Hospital - Rigshospitalet - Copenhagen, Denmark
- Copenhagen University Hospital - Herlev and Gentofte - Herlev, Denmark
- Odense Universitetshospital - Odense, Denmark