Clinical trial NCT05788744: Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer
Official title: Implementing Non-invasive Circulating Tumor DNA and Circular DNA Analysis in Patients With Localized Pancreatic Cancer to Optimize the Pre- and Postoperative Treatment: Predicting Recurrence and Survival and Changing Prognosis Over Time
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resectable Pancreatic Cancer
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: University of Copenhagen
name: Odense University Hospital
First posted: 2023-03-29
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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 outcomes:
measure: Sub-study 1 ctDNA
timeFrame: 36 months
measure: Sub-study 1 eccDNA
timeFrame: 36 months
measure: Sub-study 2 ctDNA DFS
timeFrame: 3 years from surgery for PDAC
measure: Sub-study 2 ctDNA OS
timeFrame: 3 years from surgery for PDAC
measure: Sub-study 2 eccDNA
timeFrame: 3 years from surgery for PDAC
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Rigshospitalet
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev and Gentofte
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
affiliation: Copenhagen University Hospital - Herlev and Gentofte
name: Julia S Johansen, MD
role: PRINCIPAL_INVESTIGATOR
References: