Radiology Registry on Pancreatic Malignancies

NCT05714111 | Recruiting

• 1 other identifier: RadonPams
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Pancreas Neoplasm; Pancreas Disease; Pancreas Cyst

Outcome Measures

Primary Outcomes (2)

• Progression- free survival

  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 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 Outcomes (1)

• Overall Survival

  From date of treatment until the date of death from any cause assessed up to 3 years

Interventions

Radiology evaluations and interventions OTHER

Diagnostic and interventional radiology procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with non-primary pancreatic disease

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Department of Radiology, IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy or intraoperatory samples according to standard of care

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Diseases; Pancreatic Cyst

Interventions

Methods

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases; Cysts

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiology

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: March 4, 2022
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2030
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

IT (1)