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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aalborg Universitetshospital
NOT_YET_RECRUITING
Aalborg
Aarhus Universitetshospital
NOT_YET_RECRUITING
Aarhus
Copenhagen University Hospital - Rigshospitalet
RECRUITING
Copenhagen
Copenhagen University Hospital - Herlev and Gentofte
NOT_YET_RECRUITING
Herlev
Odense Universitetshospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Julia S Johansen, MD
Julia.sidenius.johansen@regionh.dk
+45 38689241
Backup
Sidsel C Lindgaard, MD
sidsel.christy.lindgaard@regionh.dk
+45 38682984
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2030-01
Participants
Target number of participants: 700
Treatments
Experimental: A: 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.
No_intervention: B: Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Copenhagen, Odense University Hospital, Aarhus University Hospital
Leads: Copenhagen University Hospital at Herlev

This content was sourced from clinicaltrials.gov