Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Progression-free-survival (PFS)
研究概览
简要总结
Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings
- •Availability of biopsies obtained during EUS-FNB
- •Histological diagnosis of pancreatic ductal adenocarcinoma of any stage
- •Patients must be fit for chemotherapy administration
- •They have to express their willingness to be followed up at our pancreatic high volume centers
- •Age >18 and <80 years
- •Able to sign informed consent
排除标准
- •Histological diagnoses other than pancreatic ductal adenocarcinoma
- •Pregnancy or lactation
结局指标
主要结局
Progression-free-survival (PFS)
时间窗: From date of enrollment assessed until death or up to 2 years
To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse.
Overall survival
时间窗: From date of enrollment assessed until death or up to 2 years
To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death.
次要结局
未报告次要终点
研究者
Guido Costamagna
Professor
Catholic University of the Sacred Heart