Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
ECOG-ACRIN Cancer Research Group
Summary
The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts.
Description
PRIMARY OBJECTIVES: I. To compare the rates of unfavorable clinical outcomes in the two arms. SECONDARY OBJECTIVES: 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 report…
Eligibility
- Age range
- 50–75 years
- Sex
- All
- Healthy volunteers
- No
* 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 randomization 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…
Interventions
- ProcedureComputed Tomography
Undergo CT
- ProcedureEndoscopic Ultrasound
Undergo EUS
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Locations (352)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- University of South Alabama Mitchell Cancer InstituteMobile, Alabama
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Anchorage Radiation Therapy CenterAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska