The goal of this observational registry is to examine the changes made to pancreatic cancer surveillance management following the real-world clinical use of PancreaSure testing among individuals at increased risk for pancreatic ductal adenocarcinoma. The main question it aims to answer is, does surveillance management and intent change following the return of PancreaSure binary results.
Able to provide informed written consent and complete the survey in English or Spanish
>45 years of age
PancreaSure ordered as part of routine clinical care.
Family history in ≥ 2 first-degree relatives, or
Prior diagnosis of PDAC or other active malignancy within 3 years (except non-melanoma skin cancer).
Participation in interventional investigational studies that may bias test use.
Inability or unwillingness to comply with follow-up schedule.
The study population will consist of adults (\>45 years) at elevated risk for PDAC or otherwise identified for PDAC early detection testing by their clinician. Factors for high risk include: * Family history in ≥ 2 first-degree relatives, or * Known pathogenic germline mutation (BRCA1/2, CDKN2A, PALB2, ATM, STK11, PRSS1), or * Pancreatic cystic lesion, or * New-onset diabetes with additional risk factors, or * Clinician discretion
Cohort
Prospective
Not listed
Change in documented pancreatic surveillance management planning and intent following return of PancreaSure results, assessed within a predefined post-result window of 7-14 days following tR, relative to the documented pre-test surveillance plan and stra
Describing patterns of PancreaSure test utilization in clinical practice
Downstream clinical actions and follow-through
Realized care delivery and surveillance procedures will be assessed over a 12-month observation period following test prescription (t0). This will include the number and type of follow-up imaging (MRI, CT, EUS) within 12 months of testing; referral rates to specialty services; completion rate of recommended follow-up imaging; and how realized care compares to the pre-test surveillance plan.
Patient-reported outcomes
Perceived anxiety, satisfaction, and understanding of results. Barriers to testing
Downstream healthcare utilization patterns potentially associated with PancreaSure testing
Medical records will be reviewed to describe healthcare utilization following PancreaSure testing. Measures will include recommendations for and completion of follow-up imaging or procedures; time to completion of first follow-up imaging; and documented decisions to defer or avoid imaging or invasive procedures following the test result. When available, reasons for delayed, deferred, or avoided follow-up will also be summarized, including clinical judgment, patient preference, and access or insurance barriers. Results will be reported using counts, percentages, and descriptive summaries, as appropriate.
Clinical Outcomes During Follow-Up
Clinical outcomes observed during follow-up will be described. Among participants diagnosed with PDAC, measures will include stage at diagnosis; time in days from PancreaSure result availability to PDAC diagnosis; time in days from PancreaSure prescription to PDAC diagnosis; and survival status 12 months after diagnosis, when available. Stage and survival status will be reported using counts and percentages, and time-to-diagnosis measures will be summarized descriptively.
Economic Outcomes Associated with PancreaSure Testing and Downstream Care
When financial or claims data are available, economic outcomes associated with PancreaSure testing and downstream diagnostic care will be described. Measures will include cumulative costs for PancreaSure testing, imaging, procedures, and specialty visits; cost per PDAC case detected during follow-up; insurance claim submission, approval, and denial patterns; allowed and paid amounts by payer type; and patient out-of-pocket expenses, including copayments, coinsurance, deductibles, and self-pay amounts. Cost per detected PDAC case will be calculated by dividing the cumulative cost of PancreaSure testing and selected downstream diagnostic services by the number of PDAC cases detected during follow-up. Monetary outcomes will be reported in U.S. dollars.
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