An interventional study of ctDNA in Resectable Pancreatic Cancer, sponsored by Copenhagen University Hospital at Herlev. Recruiting at 5 sites in Denmark. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Copenhagen University Hospital at Herlev · Not applicable, Interventional, and Basic science
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.
The aim of the CIRCPAC study is to evaluate if plasma ctDNA from patients scheduled for surgical resection of PDAC can identify patients who will benefit from surgery and if plasma ctDNA can identify recurrence earlier and improve the survival and quality of life of the patients compared with standard-of-care surveillance.
Patients operated for PDAC will be included in this Danish multicenter study including an observational study (Sub-study 1: 700 patients) and an interventional randomized trial (Sub-study 2: 410 patients).
In Sub-study 1, patients will have blood samples drawn prior to surgery, 4 weeks after surgery, and 6 months after surgery.
In Sub-study 2, patients without recurrence 4 months after surgery, will be randomized in a 1:1 manor to an experimental arm (arm A) with ctDNA guided surveillance, or to a control arm (B) with standard surveillance.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Copenhagen University Hospital at Herlev is the lead sponsor of 77 studies on the registry; 9 are open to participants now.
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Sub-study 2: .
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive surveillance with liver enzymes, CA 19-9, history, clinical evaluation of signs of recurrence (e.g. weight loss, abdominal pain or fatigue) in combination with analysis of plasma ctDNA (90 ml blood drawn per visit) every 3 months until disease progression or up to 36 months. If plasma ctDNA is positive the patient will have a CT scan (thorax and abdomen) and EUS every 3 months for 2 years and then every 6 months until disease recurrence or up to 36 months. If plasma ctDNA is negative the patient will have CT scan of thorax and abdomen and EUS every 6 months until disease recurrence or up to 36 months. Plasma eccDNA will be determined at the same time as ctDNA but a positive eccDNA result will not be informed to the patients.
Diagnostic Test: ctDNA
Patients will receive surveillance until recurrence according to current Danish guidelines with liver enzymes, history and clinical evaluation every 3 months for two years and then every 6 months until 36 months. If an increase in liver enzymes is seen or clinical signs of recurrence (e.g. weight loss, abdominal pain or fatigue) patients will have a CT scan of thorax and abdomen. Blood samples (90 ml blood per visit) will be collected at the same time points as blood is drawn for liver enzymes (i.e. every 6 months until 36 months) for later analysis at the end of study of plasma ctDNA and eccDNA. These measurements will serve to enable post-trial comparison of oncological outcomes for the two arms.
ctDNA guided surveillance
Also known as: eccDNA
Sub-study 1 ctDNA
Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.
Time frame: 36 months
Sub-study 1 eccDNA
Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.
Time frame: 36 months
Sub-study 2 ctDNA DFS
Number of patients with recurrence assessed by ctDNA
Time frame: 3 years from surgery for PDAC
Sub-study 2 ctDNA OS
Overall survival of patients in arm A compared with patients in Arm B
Time frame: 3 years from surgery for PDAC
Sub-study 2 eccDNA
Number of patients with recurrence assessed by eccDNA
Time frame: 3 years from surgery for PDAC
Plan to share: No — If sharing through anonymization is possible, then yes.
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Copenhagen University Hospital at Herlev