Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Resectable Pancreatic Cancer
• Interventions: Diagnostic Test: ctDNA

• Registration Number: NCT05788744
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Study Timeline

• Study First Submitted: 2022-11-23
• Study Start: 2023-01-01
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29
• Primary Completion: 2027-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Experimental	ctDNA	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.

Primary Outcome Measures

Name	Time	Method
Sub-study 1 ctDNA	36 months	Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.
Sub-study 2 ctDNA OS	3 years from surgery for PDAC	Overall survival of patients in arm A compared with patients in Arm B
Sub-study 2 eccDNA	3 years from surgery for PDAC	Number of patients with recurrence assessed by eccDNA
Sub-study 1 eccDNA	36 months	Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.
Sub-study 2 ctDNA DFS	3 years from surgery for PDAC	Number of patients with recurrence assessed by ctDNA

Trial Locations

Locations (5)

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Aalborg Universitetshospital; 🇩🇰 Aalborg, Denmark

Aarhus Universitetshospital; 🇩🇰 Aarhus, Denmark

Copenhagen University Hospital - Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Copenhagen University Hospital - Herlev and Gentofte; 🇩🇰 Herlev, Denmark