Trials / Unknown
UnknownNCT04024358
A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- Massimo Falconi · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2019-07-18
- Last updated
- 2024-03-12
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04024358. Inclusion in this directory is not an endorsement.