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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Sub-study 1 ctDNA
研究概览
简要总结
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.
详细描述
The aim of the CIRCPAC study is to evaluate if plasma ctDNA from patients scheduled for surgical resection of PDAC can identify patients who will benefit from surgery and if plasma ctDNA can identify recurrence earlier and improve the survival and quality of life of the patients compared with standard-of-care surveillance.
Patients operated for PDAC will be included in this Danish multicenter study including an observational study (Sub-study 1: 700 patients) and an interventional randomized trial (Sub-study 2: 410 patients).
In Sub-study 1, patients will have blood samples drawn prior to surgery, 4 weeks after surgery, and 6 months after surgery.
In Sub-study 2, patients without recurrence 4 months after surgery, will be randomized in a 1:1 manor to an experimental arm (arm A) with ctDNA guided surveillance, or to a control arm (B) with standard surveillance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Sub-study 1 ctDNA
时间窗: 36 months
Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.
Sub-study 2 ctDNA OS
时间窗: 3 years from surgery for PDAC
Overall survival of patients in arm A compared with patients in Arm B
Sub-study 2 eccDNA
时间窗: 3 years from surgery for PDAC
Number of patients with recurrence assessed by eccDNA
Sub-study 1 eccDNA
时间窗: 36 months
Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.
Sub-study 2 ctDNA DFS
时间窗: 3 years from surgery for PDAC
Number of patients with recurrence assessed by ctDNA
次要结局
未报告次要终点
研究者
Prof. Julia Sidenius Johansen
Professor
Copenhagen University Hospital at Herlev