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Trial Title:
Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer
NCT ID:
NCT05788744
Condition:
Resectable Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ctDNA
Description:
ctDNA guided surveillance
Arm group label:
A: Experimental
Other name:
eccDNA
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aalborg Universitetshospital
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
NA NA
Facility:
Name:
Aarhus Universitetshospital
Address:
City:
Aarhus
Zip:
8000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
NA NA
Facility:
Name:
Copenhagen University Hospital - Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Carsten P Hansen, MD
Email:
Carsten.Palnaes.Hansen@regionh.dk
Facility:
Name:
Copenhagen University Hospital - Herlev and Gentofte
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Sidsel C Lindgaard, MD
Phone:
38682984
Email:
sidsel.christy.lindgaard@regionh.dk
Facility:
Name:
Odense Universitetshospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
NA NA
Start date:
January 1, 2023
Completion date:
January 2030
Lead sponsor:
Agency:
Copenhagen University Hospital at Herlev
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Copenhagen
Agency class:
Other
Collaborator:
Agency:
Odense University Hospital
Agency class:
Other
Source:
Copenhagen University Hospital at Herlev
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05788744
