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出境医 / 临床实验 / A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer (VANISSh)

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

Study Description
Brief 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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Official Title: A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. PNI and VI correlation with DFS [ Time Frame: Up to 36 months ]
    Analyze if the severity of perineural and perivascular invasion correlates with disease free survival


Secondary Outcome Measures :
  1. PNI and VI correlation with other clinical variables [ Time Frame: Up to 6 years ]
    Analyze if the severity of perineural and perivascular invasion correlates with major clinical variables such as early recurrence, site of recurrence, overall survival.

  2. PNI and VI correlation with neoadjuvant treatment [ Time Frame: Up to 12 months ]
    Analyze if neoadjuvant treatment impacts the severity of perineural and perivascular invasion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with a confirmed pancreatic ductal adenocarcinoma at the histological examination after surgery with resective purposes.
Criteria

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.
Contacts and Locations

Contacts
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Contact: Giulia Gasparini 0226437811 gasparini.giulia@hsr.it

Locations
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Italy
IRCCS San Raffaele Recruiting
Milan, Italy, 20132
Contact: Massimo Falconi, MD    0226436046    falconi.massimo@hsr.it   
Sponsors and Collaborators
Massimo Falconi
Investigators
Layout table for investigator information
Principal Investigator: Marco Schiavo Lena IRCCS Ospedale San Raffaele
Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 18, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date January 1, 2015
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019) 		PNI and VI correlation with DFS [ Time Frame: Up to 36 months ]
Analyze if the severity of perineural and perivascular invasion correlates with disease free survival
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 17, 2019)
  • PNI and VI correlation with other clinical variables [ Time Frame: Up to 6 years ]
    Analyze if the severity of perineural and perivascular invasion correlates with major clinical variables such as early recurrence, site of recurrence, overall survival.
  • PNI and VI correlation with neoadjuvant treatment [ Time Frame: Up to 12 months ]
    Analyze if neoadjuvant treatment impacts the severity of perineural and perivascular invasion.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer
Official Title A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer
Brief 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).
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a confirmed pancreatic ductal adenocarcinoma at the histological examination after surgery with resective purposes.
Condition Pancreas Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2019) 		500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Giulia Gasparini 0226437811 gasparini.giulia@hsr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024358
Other Study ID Numbers VANISSh
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Massimo Falconi, IRCCS San Raffaele
Study Sponsor Massimo Falconi
Collaborators Not Provided
Investigators
Principal Investigator: Marco Schiavo Lena IRCCS Ospedale San Raffaele
PRS Account IRCCS San Raffaele
Verification Date July 2019

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