Radiology Registry on Pancreatic Malignancies (RadonPams)

April 11, 2024 updated by: Francesco De Cobelli, IRCCS San Raffaele
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Department of Radiology, IRCCS Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Diego Palumbo, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, rare forms of pancreatic cancer (such as ampullary cancer, adenosquamous carcinomas, squamous cell carcinomas, signet ring cell carcinomas, undifferentiated carcinomas, and undifferentiated carcinomas with giant cells) and cystic neoplasms.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression- free survival
Time Frame: 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
From date of intervention until the date of first documented progression, up to a maximum of 3 years
Local progression free survival
Time Frame: 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
From date of intervention until the date of first documented local progression assessed up to a maximum of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 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
From date of treatment until the date of death from any cause assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2022

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2030

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RadonPams

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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