Actively Recruiting
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-27
770
Participants Needed
424
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
ECOG-ACRIN Cancer Research Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different monitoring approaches for pancreatic cysts and associated biomarkers to improve risk detection of progression to pancreatic cancer. This observational study aims to compare more frequent versus less frequent monitoring schedules and identify biomarkers from blood tests and imaging that may better predict the development of concerning features or high-risk signs. The study also assesses patient quality of life, financial distress, anxiety, and healthcare costs related to these surveillance programs. Participants undergo magnetic resonance imaging MRI, computed tomography CT, or endoscopic ultrasound EUS scans, as well as blood sample collections throughout the trial. The study originally randomized patients into two surveillance arms a low-intensity group with less frequent imaging and a high-intensity group with more frequent imaging based on cyst size. Patients may also undergo biopsies, fine needle aspiration, and surgery as clinically needed. The study is closed to new accrual but continues follow-up. Participants are followed every 6 to 12 months for up to 5 years after enrollment. Researchers collect imaging results, blood samples, and clinical data to track the development of worrisome cyst features or high-risk stigmata. They also evaluate patient-reported outcomes including quality of life, anxiety, and financial distress. Safety and treatment pathways are documented, and the primary outcome focuses on the time to detecting concerning cyst features on imaging over the 5-year period.
CONDITIONS
Brief Title
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is between 50 and 75 years old
- Patient does not have acute pancreatitis or a history of chronic pancreatitis
- Patient has had a CT, MRI, or EUS within 6 months prior to enrollment showing one or more pancreatic cysts at least 1 cm
- Patients who can become pregnant must not be pregnant
- Patient has no prior diagnosis of any pancreatic cancer
- Patient has no history of pancreatic surgery
- Patient does not have only pancreatic lesions without malignant risk (such as pancreatic pseudocyst or classic serous cystic lesion)
- Patient has no family history of pancreatic adenocarcinoma in first-degree relatives
- Patient does not have pancreatic cyst features requiring immediate surgery (such as enhancing mural nodule, solid cyst component, pancreatic duct 10 mm or larger, or cyst causing jaundice)
- Patient has no other illness preventing endoscopic ultrasound or cyst surgery
- Patient has not been in pancreatic cyst surveillance for more than 1 year with up-to-date imaging
You will not qualify if you...
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