ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma
- Conditions
- Pancreatic Cancer Resectable
- Registration Number
- NCT05479708
- Lead Sponsor
- BAIYONG SHEN
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death and overall survival 3 years Overall survival difference between MRD-positive and MRD-negative patients
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine🇨🇳Shanghai, Shanghai, China