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

About

Brief 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.

Study Type

Observational

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

50 Years

Maximum Age

75 Years

Inclusion Criteria:

Patient must be ≥ 50 years and ≤ 75 years of age
Patient must not have acute pancreatitis or a history of chronic pancreatitis
Patient must have received a CT, MRI, or EUS within 6 months prior to enrollment that revealed one or more ≥ 1 cm pancreatic cyst(s).
Patients of childbearing potential must not be known to be pregnant
Patient must not have a prior diagnosis of pancreatic malignancy of any type
Patient must not have a history of pancreatic resection
Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible
Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children)
Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥ 10mm, cyst causing obstructive jaundice)
Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection
Patient must not be in any form of pancreatic cyst surveillance for > 1 year, defined as organized, periodic up-to-date imaging directed towards the pancreatic cyst of interest
PRIOR TO ADDENDUM #5 08/13/2024: Patient must be ≥ 50 years and ≤ 75 years of age
PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have acute pancreatitis or a history of chronic pancreatitis.
PRIOR TO ADDENDUM #5 08/13/2024: Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s).
PRIOR TO ADDENDUM #5 08/13/2024: Patients of childbearing potential must not be known to be pregnant.
PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a prior diagnosis of pancreatic malignancy of any type.
PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a history of pancreatic resection.
PRIOR TO ADDENDUM #5 08/13/2024: Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible.
PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children).
PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥10mm, cyst causing obstructive jaundice).
PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection.