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

Pancreas Cancer Clinical Trial

— VANISSh  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04024358
• Other study ID #: VANISSh
• Status: Active, not recruiting
• Start date: January 1, 2015
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Massimo Falconi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PNI and VI correlation with neoadjuvant treatment	Analyze if neoadjuvant treatment impacts the severity of perineural and perivascular invasion.	Up to 12 months
Secondary	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