Radiology Registry on Pancreatic Malignancies

Recruiting

• Conditions: Pancreas Cyst; Pancreatic Cancer; Pancreas Neoplasm; Pancreas Disease

• Registration Number: NCT05714111
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

The purpose of this study is to collect all radiological data which evaluated with clinical data may help assess malignancy and prognosis of pancreatic disease.This registry aims to collect retrospective data from 2014 and prospective data until 2027 with a maximum follow-up of 3 years per patient.

Detailed Description

Single center, observational (retrospective and prospective) will collect all available parameters to assess the clinical outcome of the patients (progression free survival (PFS), overall survival (OS), local progression free survival LTPFS), response to treatment) with pancreatic neoplasms presenting to San Raffaele. Patient assignment to a given diagnostic and/or therapeutic procedure is not related to random assignment methods but is part of the ordinary therapeutic strategy planned for each patient on an individual basis and after multidisciplinary discussion.

Study Timeline

• Study Start: 2022-03-04
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2027-03-30
• Study Completion: 2030-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

• ≥18 years of age
• Patients with suspect (planned for investigation) or diagnosed pancreatic cancer at any stage.
• able and willing to sign informed consent

Exclusion Criteria

• Patients with non-primary pancreatic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression- free survival	From date of intervention until the date of first documented progression, up to a maximum of 3 years	Time from start of observation to disease progression
Local progression free survival	From date of intervention until the date of first documented local progression assessed up to a maximum of 3 years	Time between (start of) a locoregional treatment and local disease progression

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From date of treatment until the date of death from any cause assessed up to 3 years	The length of time from either the date of diagnosis or the start of treatment for a disease, in which the patients are still alive

Trial Locations

Locations (1)

Department of Radiology, IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy