ClinicalTrials.gg
RecruitingNCT05788744CIRCPACUpdated Mar 27, 2026

Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

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

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Sex
All
01

Study 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.

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.

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Conditions studied

  • Resectable Pancreatic Cancer
03

In context

Pancreatic Neoplasms

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 →

Lead sponsor

Copenhagen University Hospital at Herlev is the lead sponsor of 77 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sub-study 1: Suspicion of PDAC tumor stage I-III, scheduled for pancreatic resection, with or without preoperative chemotherapy.
  • Sub-study 2: .

    • PDAC tumor stage I-III
    • Has received intended curative resection (R0/R1) of PDAC
    • No signs of local recurrence or disease at a CT scan 4 months after the operation

Exclusion criteria

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
Terms in these criteria, in plain language(2)

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    A: 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.

    Diagnostic Test: ctDNA

  • No intervention
    B: Control

    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.

Interventions

  • Diagnostic testctDNA

    ctDNA guided surveillance

    Also known as: eccDNA

06

What researchers measure

Primary outcomes

  1. Sub-study 1 ctDNA

    Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.

    Time frame: 36 months

  2. Sub-study 1 eccDNA

    Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.

    Time frame: 36 months

  3. Sub-study 2 ctDNA DFS

    Number of patients with recurrence assessed by ctDNA

    Time frame: 3 years from surgery for PDAC

  4. 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

  5. Sub-study 2 eccDNA

    Number of patients with recurrence assessed by eccDNA

    Time frame: 3 years from surgery for PDAC

07

Study locations

5 of 5 sites recruiting
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References and documents

Individual participant data

Plan to share: No — If sharing through anonymization is possible, then yes.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05788744
Lead sponsor
Copenhagen University Hospital at Herlev
Responsible party
Prof. Julia Sidenius Johansen (Professor, Copenhagen University Hospital at Herlev) — Principal investigator
First posted
Mar 29, 2023
Start date
Jan 1, 2023
Primary completion
Jan 2029 (estimated)
Completion
Jan 2032 (estimated)
Last update
Mar 27, 2026

Study contacts

Julia S Johansen, MD
Contact
Julia.sidenius.johansen@regionh.dk
+45 38689241
Sidsel C Lindgaard, MD
Contact
sidsel.christy.lindgaard@regionh.dk
+45 38682984
Julia S Johansen, MD
principal investigator · Copenhagen University Hospital - Herlev and Gentofte

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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