Postoperative ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Death and overall survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Signed informed consent
排除标准
- •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
结局指标
主要结局
Death and overall survival
时间窗: 3 years
Overall survival difference between MRD-positive and MRD-negative patients
次要结局
未报告次要终点
研究者
BAIYONG SHEN
Professor
Ruijin Hospital