A New Scoring System For Perineural And Vascular Invasion In Pancreatic Cancer

Study Overview

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

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.

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 ⊫sent"), 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).

Pancreas Cancer

VANISSh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-07-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-10
First Submitted that Met QC Criteria 2019-07-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-12
First Posted (ACTUAL) 2019-07-18	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
PNI and VI correlation with DFS	Analyze if the severity of perineural and perivascular invasion correlates with disease free survival	Up to 36 months

Secondary Outcome Measures	Measure Description	Time Frame
PNI and VI correlation with other clinical variables	Analyze if the severity of perineural and perivascular invasion correlates with major clinical variables such as early recurrence, site of recurrence, overall survival.	Up to 6 years
PNI and VI correlation with neoadjuvant treatment	Analyze if neoadjuvant treatment impacts the severity of perineural and perivascular invasion.	Up to 12 months
Correlation of neurotoxicity with PNI	For patients undergoing chemotherapeutic treatment, correlate (if experienced) neurotoxic side effects with PNI presence and scoring system to treatment response	Up to 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Marco Schiavo Lena, IRCCS Ospedale San Raffaele

Publications

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General Publications

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Clinical Trial Record