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

PRIMARY OBJECTIVE:

I. Evaluate whether the protocol specified primary biomarkers (both blood and imaging-based) measured at baseline, are associated with the future development of worrisome features and/or high-risk stigmata.

SECONDARY OBJECTIVES:

I. Evaluate whether the imaging-based secondary biomarker implemented using baseline computed tomography (CT) scans and/or the blood-based secondary biomarker panel, is associated with the future development of worrisome features and/or high-risk stigmata.

II. Estimate area under curve (AUC), sensitivity, specificity, negative, and positive predictive value of each biomarker.

III. Evaluate the predictive ability of the longitudinal trajectory of each biomarker for prediction of worrisome features and/or high-risk stigmata.

IV. Develop and evaluate risk scores that combine blood-based and imaging-based markers.

V. Compare patient reported outcomes (PROs) between study arms (A and B): quality of life (QOL), financial distress, and situational anxiety.

VI. Compare 5-year total cost between arms (A and B).

PRIMARY OBJECTIVE (PRIOR TO ADDENDUM #5 08/13/2024):

I. To compare the rates of unfavorable clinical outcomes in the two arms.

SECONDARY OBJECTIVES (PRIOR TO ADDENDUM #5 08/13/2024):

I. To compare rates of major surgical morbidity and/or mortality between arms. II. To compare pancreatic cancer incidence and all-cause mortality across arms. III. Compare institutional (direct) costs. IV. Compare healthcare utilization of imaging, invasive testing, surgical, and other procedures across the two surveillance arms.

V. Compare patient (out-of-pocket and other indirect) costs. VI. Describe diagnostic test and treatment pathways by arm. VII. Compare patient reports of QOL, situational anxiety. VIII. Compare patient report of financial distress. IX. Compare rates of non-adherence by arm assignment. X. To evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.

EXPLORATORY OBJECTIVE (PRIOR TO ADDENDUM #5 08/13/2024):

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

OUTLINE: This is an observational study.

Patients undergo magnetic resonance imaging (MRI) or CT scans as well as blood sample collection throughout the trial. Patients undergo endoscopic ultrasound (EUS), fine needle aspiration (FNA), biopsy and surgery as clinically indicated.

Patients are followed up every 6 months or yearly for 5 years from the date of registration.

OUTLINE (PRIOR TO ADDENDUM #5 08/13/2024): This is an observational study. Patients are randomized to 1 of 2 arms.

ARM A (LOW INTENSITY SURVEILLANCE) (CLOSED TO ACCRUAL 08/13/2024): Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years.

ARM B (HIGH INTENSITY SURVEILLANCE) (CLOSED TO ACCRUAL 08/13/2024): Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with \>= 1 and \< 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with \>= 2 and \< 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst \>= 3 cm undergo alternate MRI or CT with EUS every 3-6 months.

All patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study.

After completion of imaging procedures, patients are followed up for 5 years from the date of registration.

• Finding of a worrisome feature and/or high-risk stigmata on CT or MRI [Срок оценки: Up to 5 years]
• Situational anxiety [Срок оценки: Up to 5 years]
• Overall quality of life [Срок оценки: Up to 5 years]
• Financial distress [Срок оценки: Up to 5 years]
• Cost [Срок оценки: Up to 5 years]
• Surgical and all-cause mortality (PRIOR TO ADDENDUM #5 08/13/2024) [Срок оценки: Up to 5 years]
• Major surgical morbidity (PRIOR TO ADDENDUM #5 08/13/2024) [Срок оценки: Up to 5 years]
• Pancreatic cancer incidence (PRIOR TO ADDENDUM #5 08/13/2024) [Срок оценки: Up to 5 years]
• Institutional (direct) costs (PRIOR TO ADDENDUM #5 08/13/2024) [Срок оценки: Up to 5 years]
• Healthcare utilization of imaging, invasive testing, surgical, and other procedures (PRIOR TO ADDENDUM #5 08/13/2024) [Срок оценки: Up to 5 years]
• Patient (out-of-pocket and other indirect) costs (PRIOR TO ADDENDUM #5 08/13/2024) [Срок оценки: Up to 5 years]
• Diagnostic test and treatment pathways (PRIOR TO ADDENDUM #5 08/13/2024) [Срок оценки: Up to 5 years]