Resectable Pancreatic CancerCIRCPACNCT05788744
Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer
A study testing ctDNA in people with Resectable Pancreatic Cancer, run by Copenhagen University Hospital at Herlev at 5 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resectable Pancreatic Cancer
- What is being tested?
- ctDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Jan 2023to Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Recruiting
Aalborg Universitetshospital
Aalborg, 9000
Ole Thorlacius-Ussing, otu@rn.dk
- Recruiting
Aarhus Universitetshospital
Aarhus, 8000
Mai-Britt W Oerntoft, mwo@clin.au.dk
- Recruiting
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100
Carsten P Hansen, MD, Carsten.Palnaes.Hansen@regionh.dk
- Recruiting
Copenhagen University Hospital - Herlev and Gentofte
Herlev, 2730
Sidsel C Lindgaard, MD, 38682984, sidsel.christy.lindgaard@regionh.dk
- Recruiting
Odense Universitetshospital
Odense, 5000
Michael B Mortensen, michael.bau.mortensen@rsyd.dk
About this study
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
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.
Read the 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.
- Conditions
- Resectable Pancreatic Cancer
- Being tested
- ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNADiagnostic test
Also called eccDNA
ctDNA guided surveillance
| Study group | Role | What they receive |
|---|---|---|
| A: Experimental | Experimental | 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. Receives: Diagnostic Test: ctDNA |
| B: Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-study 1 ctDNA
Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.
Measured: 36 months
Sub-study 1 eccDNA
Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.
Measured: 36 months
Sub-study 2 ctDNA DFS
Number of patients with recurrence assessed by ctDNA
Measured: 3 years from surgery for PDAC
Sub-study 2 ctDNA OS
Overall survival of patients in arm A compared with patients in Arm B
Measured: 3 years from surgery for PDAC
Sub-study 2 eccDNA
Number of patients with recurrence assessed by eccDNA
Measured: 3 years from surgery for PDAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Jan 2023
- Primary completionJan 2029 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Julia Sidenius Johansen, Copenhagen University Hospital at Herlev
- Investigators
- Julia S Johansen, MD, Principal investigator, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788744
- Sponsor's protocol ID
- CIRCPAC
- Acronym
- CIRCPAC
- Status last verified
- Mar 2026
- First submitted
- 23 Nov 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If sharing through anonymization is possible, then yes.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05788744
- Acronym / sponsor ID
- CIRCPAC / CIRCPAC
- Conditions
- Resectable Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Copenhagen, Odense University Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Experimental | Experimental | Diagnostic Test: ctDNAPatients 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. |
| B: Control | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Sub-study 1: Suspicion of PDAC tumor stage I-III, scheduled for pancreatic resection, with or without preoperative neoadjuvant chemotherapy.
- Sub-study 2: .
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ctDNAAlso: eccDNActDNA guided surveillance | Diagnostic test | A: Experimental |
Primary outcome
Sub-study 1 ctDNA
Time frame: 36 months
Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.
Sub-study 1 eccDNA
Time frame: 36 months
Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.
Sub-study 2 ctDNA DFS
Time frame: 3 years from surgery for PDAC
Number of patients with recurrence assessed by ctDNA
Sub-study 2 ctDNA OS
Time frame: 3 years from surgery for PDAC
Overall survival of patients in arm A compared with patients in Arm B
Sub-study 2 eccDNA
Time frame: 3 years from surgery for PDAC
Number of patients with recurrence assessed by eccDNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. If sharing through anonymization is possible, then yes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia S Johansen, MD principal investigator
Copenhagen University Hospital - Herlev and Gentofte
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ctDNA in people with Resectable Pancreatic Cancer, run by Copenhagen University Hospital at Herlev at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia S Johansen, MD (+45 38689241, Julia.sidenius.johansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sub-study 1 ctDNA (time frame: 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.