Using blood tests to predict outcomes in patients with localized pancreatic cancer
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
This study is testing if blood tests that look for specific DNA can help predict how well patients with localized pancreatic cancer will do after surgery and improve their follow-up care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Copenhagen University Hospital at Herlev Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Trial ID | NCT05788744 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of plasma circulating tumor DNA (ctDNA) and circular DNA (eccDNA) in predicting early recurrence and overall survival in patients with localized pancreatic ductal adenocarcinoma (PDAC) scheduled for surgical resection. The study includes an observational component where blood samples will be collected at various intervals, and an interventional randomized trial comparing ctDNA-guided surveillance to standard surveillance in patients without recurrence four months post-surgery. The goal is to determine if ctDNA can enhance patient outcomes by identifying those who will benefit from surgery and improving surveillance methods.
Who should consider this trial
Good fit: Ideal candidates are patients with suspected PDAC tumor stages I-III who are scheduled for surgical resection.
Not a fit: Patients with other cancers or those unlikely to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with localized pancreatic cancer.
How similar studies have performed: Other studies have shown promise in using ctDNA for cancer monitoring, suggesting potential success for this approach in pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 4 other locations
- Aalborg Universitetshospital — Aalborg, Denmark (Recruiting)
- Aarhus Universitetshospital — Aarhus, Denmark (Recruiting)
- Copenhagen University Hospital - Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Copenhagen University Hospital - Herlev and Gentofte — Herlev, Denmark (Recruiting)
- Odense Universitetshospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Julia S Johansen, MD — Copenhagen University Hospital - Herlev and Gentofte
- Study coordinator: Julia S Johansen, MD
- Email: Julia.sidenius.johansen@regionh.dk
- Phone: +45 38689241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.