Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

Resectable Pancreatic Cancer Clinical Trial

— CIRCPAC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788744
• Other study ID #: CIRCPAC
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 2030

Study information

• Verified date: March 2023
• Source: Copenhagen University Hospital at Herlev
• Contact: Julia S Johansen, MD
• Phone: +45 38689241
• Email: Julia.sidenius.johansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 overall survival compared with standard-of-care surveillance.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 2030
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Resectable Pancreatic Cancer

Intervention

Diagnostic Test:
• ctDNA
ctDNA guided surveillance

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Copenhagen University Hospital - Rigshospitalet	Copenhagen
Denmark	Copenhagen University Hospital - Herlev and Gentofte	Herlev
Denmark	Odense Universitetshospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Aarhus University Hospital, Odense University Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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