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

Condition(s) studied

Investigational drug(s) / intervention(s)

Biopsy Procedure: Undergo biopsy

Biospecimen Collection: Undergo blood sample collection

Computed Tomography: Undergo CT

Endoscopic Ultrasound: Undergo EUS

Endoscopic Ultrasound-Guided Fine-Needle Aspiration: Undergo EUS-FNA

Magnetic Resonance Imaging: Undergo MRI

Quality-of-Life Assessment: Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)

Questionnaire Administration: Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)

Surgical Procedure: Undergo surgery

Study summary

The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.

Eligibility

Primary outcome measure(s)

• Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI) — Up to 5 years
  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) — Up to 5 years
  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.

Trial sites (429)

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