Resectable Pancreatic Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTctDNA
ctDNA guided surveillance
Sponsors
Copenhagen University Hospital at Herlev
Aarhus University Hospital
University of Copenhagen
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Contacts
CONTACTJulia S Johansen, MD
CONTACTSidsel C Lindgaard, MD
PRINCIPAL_INVESTIGATORJulia S Johansen, MD
Copenhagen University Hospital - Herlev and Gentofte
Outcome results
None listed