The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.
Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.
Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).
Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND
Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).
Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.
Individuals with any active metastatic cancer.
Individuals who are unable to give informed consent.
Individuals who are under the age of 18 (infants, children, teenagers).
Single group
Screening Blood Tests
Other interventionCarbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.
Endoscopic Ultrasound
Diagnostic testAnnually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Magnetic Resonance Imaging
Combination productAnnually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Magnetic Resonance Cholangiopancreatography
Combination productAnnually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.
Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms
Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period.
Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (\>35U/mL or \>=20% increase) or diabetes (FBG \>100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score \>=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit.
Positive Predictive Value of Blood Assays
Positive predictive value of blood assays, defined as newly positive CA19-9 (\>35U/mL or \>=20% increase) or diabetes (FBG \>100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score \>=3, with a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a positive blood assay.
Negative Predictive Value of Blood Assays
Negative predictive value of blood assays, defined as CA19-9 (\<=35U/mL or \<20% increase) or diabetes (FBG \<100mg/dL for first time or HgbA1c increased by less than 0.5) assay result or ENDPAC score \<3, without a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a negative blood assay.
Proportion of Screen-Detected, Resected Pancreatic Lesions
Number of screen-detected pancreatic lesions that are resected compared to the total number of screen-detected pancreatic lesions.
Proportion of Non-Worrisome Pancreatic Lesions
Number of pancreatic lesions that are biopsied without cancer or high-grade dysplasia divided by number of pancreatic lesions that are biopsied.
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