RadonPams: Radiology Registry on Pancreatic Malignancies

• Sponsor: IRCCS San Raffaele (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05714111
• Collaborator: (none)
• Enrollment: 1,300
• Location: 1
• Anticipated Duration (Months): 96.9
• Patients Per Site Per Month: 13.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer; Pancreas Neoplasm; Pancreas Disease; Pancreas Cyst	Other: Radiology evaluations and interventions

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1300 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Radiology Registry on Pancreatic Malignancies
• Actual Study Start Date: Mar 4, 2022
• Anticipated Primary Completion Date: Mar 30, 2027
• Anticipated Study Completion Date: Mar 30, 2030

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology, IRCCS Ospedale San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

• IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Francesco De Cobelli, Head of Radiology, IRCCS San Raffaele
• ClinicalTrials.gov Identifier: NCT05714111
• Other Study ID Numbers: RadonPams
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Pancreatic Cyst; Pancreatic Diseases

Study Results

No Results Posted as of Feb 6, 2023