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NCT Number: NCT05788744

Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

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.

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Key information

Conditions

Resectable Pancreatic Cancer

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Universitetshospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ctDNA

Diagnostic Test

ctDNA guided surveillance

Other names: eccDNA

Primary outcomes

  1. Sub-study 1 ctDNA

    Time frame: 36 months

    Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.

  2. Sub-study 1 eccDNA

    Time frame: 36 months

    Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.

  3. Sub-study 2 ctDNA DFS

    Time frame: 3 years from surgery for PDAC

    Number of patients with recurrence assessed by ctDNA

  4. 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

  5. Sub-study 2 eccDNA

    Time frame: 3 years from surgery for PDAC

    Number of patients with recurrence assessed by eccDNA

Study contacts

Contact information is provided by the study sponsor or research team.

Julia S Johansen, MD

CONTACT

[email protected]

+45 38689241

Sidsel C Lindgaard, MD

CONTACT

[email protected]

+45 38682984

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Collaborators

  • Aarhus University Hospital
  • Odense University Hospital
  • University of Copenhagen

Registry information

Official study 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

Acronym: CIRCPAC

Important dates

Study start
2023
Primary completion
2029
Study completion
2032
First posted
Mar 29, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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