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

NCT ID: NCT04024358

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2025-01-01

Brief Summary

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.

Detailed Description

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).

Conditions

Pancreas Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Age < 18 years.
• Patients with other ongoing oncological diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massimo Falconi

OTHER

Sponsor Role: lead

Responsible Party

Massimo Falconi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marco Schiavo Lena

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

IRCCS San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

VANISSh

Identifier Type: -

Identifier Source: org_study_id