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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreas Cancer

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).

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

• Study Contact: Name: Giulia Gasparini; Phone Number: 0226437811; Email: gasparini.giulia@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • IRCCS San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed pancreatic ductal adenocarcinoma at the histological examination after surgery with resective purposes.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Massimo Falconi
• Investigators: Principal Investigator: Marco Schiavo Lena, IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: neural invasion; vascular invasion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: VANISSh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED