ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma
China150 participantsStarted 2023-08-09
Plain-language summary
Short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (PAAD) after surgeries. Despite the importance of adjuvant treatments for resected PAAD patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. In this study, we aim to examine whether postoperative circulating tumor DNA (ctDNA) could be used as a biomarker for early detection of minimal residual disease (MRD) and predicting relapse in resected PAAD through high-depth targeted next-generation sequencing.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically diagnosed pancreatic adenocarcinoma (stage I-III)
* KRAS mutations identified in resected tumor tissues
* Margin negative (R0) or no imaging recurrence/metastasis and CA 19-9\<37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Receiving adjuvant chemotherapy
* ECOG 0-2
* Signed informed consent
Exclusion Criteria:
* With serious internal medicine diseases, infectious diseases, other solid tumors (except PAAD) or hematologic disorders
* Distant organ metastasis or malignant ascites
* Receiving neo-adjuvant therapy before surgery
* Imaging recurrence/metastasis or CA 19-9\>37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Pregnant or breastfeeding at time of enrollment
* Prior transplantation of bone marrow, stem cell or organ
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.