Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04024358
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Massimo Falconi, IRCCS San Raffaele

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).

Layout table for study information
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

Resource links provided by the National Library of Medicine





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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024358


Contacts
Layout table for location contacts
Contact: Giulia Gasparini 0226437811 gasparini.giulia@hsr.it

Locations
Layout table for location information
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

Layout table for additonal information
Responsible Party: Massimo Falconi, Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04024358     History of Changes
Other Study ID Numbers: VANISSh
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Massimo Falconi, IRCCS San Raffaele:
neural invasion
vascular invasion

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases