A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- PNI and VI correlation with DFS
研究概览
简要总结
The aim of this study is to validate both retrospectively and prospectively a newly proposed scoring system for perineural and vascular invasion in pancreatic ductal cancer and correlate it with disease free survival, early recurrence, site of recurrence, overall survival and neoadjuvant treatment.
详细描述
Perineural invasion (PNI) is defined as the presence of cancer cells along nerves and/or within the epineural, perineural and endoneural spaces of the neuronal sheath.Clinically, PNI is associated with increased tumor recurrence, poor survival after pancreatectomy and pain, an invalidating symptom that may impair quality of life. Pancreatic ductal adenocarcinoma has one of the highest incidences of PNI (70-100%) among all types of cancer, which correlates with a poor prognosis and decreased survival. PNI is a still not uniformly characterized or quantified event, usually it is described only dichotomously ("present" or "absent"), despite some efforts to use a more detailed scoring system. However, these scores are not specifically developed for pancreatic surgical specimen. Vascular invasion (VI), which is assumed to be associated with a more aggressive tumor biology and dissemination, lacks a specific scoring system as well. The primary aim of this study is to validate both retrospectively and prospectively a novel PNI and VI scoring system aimed at a more detailed stratification of perineural invasion, together with an accompanying scoring system for vascular invasion, and correlated them with disease free survival (DFS).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Patients undergoing all types of pancreatic resection (pancreatoduodenectomy, left pancreatectomy, total pancreatectomy, both laparotomic and laparoscopic).
- •Proven pancreatic ductal adenocarcinoma (cytology or biopsy).
- •Patients that received neoadjuvant therapy (CT +/- RT) can be included.
- •Patients able to sign the informed consent.
排除标准
- •Age < 18 years.
- •Patients with other ongoing oncological diseases.
结局指标
主要结局
PNI and VI correlation with DFS
时间窗: Up to 36 months
Analyze if the severity of perineural and perivascular invasion correlates with disease free survival
次要结局
- PNI and VI correlation with other clinical variables(Up to 6 years)
- Correlation of neurotoxicity with PNI(Up to 12 months)
- PNI and VI correlation with neoadjuvant treatment(Up to 12 months)
