Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers

Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)

Will assess the predictive performance of both primary markers separately. Time to first occurrence of worrisome features and/or high-risk stigmata will be measured from the time of baseline blood draw. Will use an overall significance level of 0.1. Will use a Bonferroni correction for multiplicity adjustment, the significance level applied to both primary biomarkers will be 0.05. Will evaluate using a two-sided log-rank test comparing time to occurrence of worrisome features and/or high-risk stigmata between the marker-positive and marker-negative subgroups. Will visually summarize time to occurrence of worrisome features and/or high-risk stigmata in both maker positive and marker negative using Kaplan-Meier curves. All biomarkers will come in with a predetermined threshold for determining marker positivity (as defined in their respective publications). The primary imaging marker is for MRI, the analysis of this biomarker will be restricted to participants with a pre-enrollment MRI.

Occurrence of an "unfavorable" outcome (PRIOR TO ADDENDUM #5 08/13/2024)

Defined as a composite of: (1) any pancreatic cancer without surgery; (2) unresectable pancreatic cancer or cancer \> T1a, N0 at surgery, and (3) benign disease at surgery will be approached from the intent-to-treat perspective. Time to the first occurrence of the primary endpoint will be measured from randomization. Survival analysis methods will be used to estimate and compare distributions of time to an unfavorable event between the study arms. In particular Kaplan-Meier estimates will be developed for each arm and a log rank test will be used to compare the two arms.

Finding of a worrisome feature and/or high-risk stigmata on CT or MRI

Will evaluate with the analog analysis plan.

Situational anxiety

Will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4-item short form. The analysis group will be the patients recruited prior to the activation of addendum #5 and randomized to either high or low intensity surveillance. A hierarchical strategy will be used. Will compare situational anxiety between arms with a two-sample unequal-variance t-test.

Overall quality of life

Will be measured using the PROMIS-10. The analysis group will be the patients recruited prior to the activation of addendum #5 and randomized to either high or low intensity surveillance. A hierarchical strategy will be used. Will compare quality of life between arms with a two-sample unequal-variance t-test.

Financial distress

Will be measured using the Comprehensive Score for Financial Toxicity measure. The analysis group will be the patients recruited prior to the activation of addendum #5 and randomized to either high or low intensity surveillance. Will compare financial distress between arms with a two-sample unequal-variance t-test.

Predictive accuracy of radiomic markers for dysplasia and pancreatic cancer (PRIOR TO ADDENDUM #5 08/13/2024)

Will evaluate and compare the predictive accuracy of known and future radiomic markers for dysplasia and pancreatic cancer.