A Prospective Registry for Patients at High-Risk for Pancreatic Cancer

Recruiting

• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma; PDAC; Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT06151223
• Lead Sponsor: Mayo Clinic

Brief Summary

This study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC) and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.The study also aims to provide a platform for development of an interventional protocol for early detection of PDAC.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-13
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2031-07-31
• Study Completion: 2031-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Age ≥ 18 year
• Able to provide written informed consent
• Meets criteria as a High-Risk Individual as defined by protocol

Exclusion Criteria

• Individual who has a personal history of pancreatic ductal adenocarcinoma (PDAC)
• History of total pancreatectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tier 2	MRI	* Individual with family history of PDAC in only one first degree relative (FDR); age ≥50 or 10 years younger than the affected first degree relative * OR known BRCA2, BRCA1, PALB2, ATM, MLH1, MSH2, or MSH6 gene mutation; age \> 45 who do not meet tier 1 criteria.

Primary Outcome Measures

Name	Time	Method
Collection of radiology images and videos	Up to 10 years	Collect and archive radiology images and videos obtained during esophagogastroduodenoscopy (EDG)-endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) in high risk individuals undergoing screening and surveillance tests. An imaging dataset designed for studies of promising imaging biomarkers and developing AI-assisted algorithms can be collected within10 years.
Collection of biospecimen samples (blood and pancreatic juice)	Up to 10 years	Sufficient biospecimens (blood and pancreatic juice) will be collected in 10 years from participants to provide a resource for nested case-control studies of promising biomarkers for discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (PDAC)..

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States