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

Mayo Clinic

Status: Enrolling

Conditions: PDAC - Pancreatic Ductal Adenocarcinoma; PDAC; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer

Treatments: Other: Bio-specimen Collection: Pancreatic Juice; Other: Bio-specimen Collection: Blood; Diagnostic Test: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT06151223

20-012752

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

5,000 participants in 2 patient groups

Tier 1

Description:

* Participants with Peutz-Jeghers syndrome and/or carriers of a germline CDKN2A mutation and/or hereditary pancreatitis with PRSS1 mutation and clinical history of pancreatitis(age ≥40 or 10 years younger than youngest affected blood relative) * Carriers of a germline BRCA2, BRCA1, PALB2, ATM, MLH1, MSH2, or MSH6 gene mutation with at least one affected first-degree blood relative (age ≥45 or 10 years younger than youngest affected blood relative) * At least one first-degree relative (FDR) with pancreatic cancer who in turn also has a first-degree relative with pancreatic cancer and/or at least two affected blood relatives on the same side of the family, of whom at least one is an FDR to the individual and/or at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual(age ≥50 or 10 years younger than youngest affected blood relative)

Treatment:

Other: Bio-specimen Collection: Blood

Other: Bio-specimen Collection: Pancreatic Juice

Tier 2

Description:

* 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.

Treatment:

Diagnostic Test: MRI

Other: Bio-specimen Collection: Blood

Other: Bio-specimen Collection: Pancreatic Juice