Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

NCT05788744 | Recruiting

• 1 other identifier: CIRCPAC
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (5)

• Sub-study 1 ctDNA

  Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.

  36 months

• Sub-study 1 eccDNA

  Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.

  36 months

• Sub-study 2 ctDNA DFS

  Number of patients with recurrence assessed by ctDNA

  3 years from surgery for PDAC

• Sub-study 2 ctDNA OS

  Overall survival of patients in arm A compared with patients in Arm B

  3 years from surgery for PDAC

• Sub-study 2 eccDNA

  Number of patients with recurrence assessed by eccDNA

  3 years from surgery for PDAC

Study Arms (2)

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.

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.

Interventions

ctDNA DIAGNOSTIC_TEST

ctDNA guided surveillance

Also known as: eccDNA

A: Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead
• Aarhus University Hospital: collaborator
• University of Copenhagen: collaborator
• Odense University Hospital: collaborator

Study Sites (5)

Aalborg Universitetshospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus Universitetshospital

Aarhus, 8000, Denmark

RECRUITING

Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Copenhagen University Hospital - Herlev and Gentofte

Herlev, 2730, Denmark

RECRUITING

Odense Universitetshospital

Odense, 5000, Denmark

RECRUITING

Study Officials

• Julia S Johansen, MD

  Copenhagen University Hospital - Herlev and Gentofte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia S Johansen, MD

CONTACT

+45 38689241; Julia.sidenius.johansen@regionh.dk

Sidsel C Lindgaard, MD

CONTACT

+45 38682984; sidsel.christy.lindgaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: March 29, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2032
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)