跳至主要内容
临床试验/NCT04024358
NCT04024358进行中(未招募)不适用

A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer

Massimo Falconi1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年1月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Massimo Falconi

Professor

IRCCS San Raffaele

研究点 (1)

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