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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pancreas Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neural invasion, vascular invasion