An observational study in Pancreas Cancer, sponsored by Massimo Falconi. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Massimo Falconi · Observational
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 "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).
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 500 is above the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Massimo Falconi is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Patients with a confirmed pancreatic ductal adenocarcinoma at the histological examination after surgery with resective purposes.
Exclusion Criteria:
PNI and VI correlation with DFS
Analyze if the severity of perineural and perivascular invasion correlates with disease free survival
Time frame: Up to 36 months
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.
Time frame: Up to 6 years
PNI and VI correlation with neoadjuvant treatment
Analyze if neoadjuvant treatment impacts the severity of perineural and perivascular invasion.
Time frame: 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
Time frame: Up to 12 months
Plan to share: Undecided
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This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Massimo Falconi