Clinical Trials

Inclusion Criteria:

Individuals without a history of PDAC meeting one or more of the following categories of criteria will be eligible for enrollment.

• PDAC Family History or PDAC-Related Genetic Mutations
  • Age: 50 or older, plus at least one of the following:
    • Mutation unknown or absent:
      • 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; OR
      • 2+ affected first degree relatives (FDR, defined as blood related parents, siblings, or children).
    • Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:
      • • CDK2NA/p16, PJS (STK11), Hereditary pancreatitis with confirmed PRSS1.
      • OR 1+ FDR or SDR with PDAC and a known P/LP mutation in one or more of:
        • ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53.
• High-Risk or Worrisome Pancreatic Cysts:
  • 18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria.
• Table 1. Imaging and Clinical Features of Pancreatic Cysts Associated with Cancer Development:
  •  High-Risk Stigmata: 
    • Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas;
    • Enhancing mural nodule ≥  5 mm;
    • Main Pancreatic Duct ≥  10 mm.
  • Worrisome Features: 
    • Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct  ≥  6 mm;
    • Cyst ≥  3 cm;
    • Enhancing mural nodule < 5 mm;
    • Thickened/Enhancing cyst wall;
    • Main duct size 5-9 mm;
    • Pancreatitis;
    • Lymphadenopathy;
    • Increased CA 19-9;
    • Cyst growth rate ≥  5 mm / 2 years.

Exclusion Criteria:

• Is unable to provide informed consent.
• Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma).
• Current or prior history of PDAC or total pancreatectomy.
• Is currently a prison inmate.
• Is not able to speak or read English.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/24/23. Questions regarding updates should be directed to the study team contact.