NCT04024358

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

10 years

First QC Date

July 16, 2019

Last Update Submit

March 10, 2024

Conditions

Pancreas Cancer

Keywords

neural invasionvascular invasion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • PNI and VI correlation with other clinical variables

    Up to 6 years

  • PNI and VI correlation with neoadjuvant treatment

    Up to 12 months

  • Correlation of neurotoxicity with PNI

    Up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a confirmed pancreatic ductal adenocarcinoma at the histological examination after surgery with resective purposes.

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 18 years.
  • Patients with other ongoing oncological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Marco Schiavo Lena

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 18, 2019

Study Start

January 1, 2015

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

IT(1)