What is this study trying to find out about pancreatic cysts?

This study is evaluating two different monitoring schedules and associated biomarkers to better detect the risk of pancreatic cysts progressing toward cancer. Researchers want to learn which monitoring method and which blood or imaging markers lead to better outcomes for patients. The ECOG-ACRIN Cancer Research Group is leading this research to improve care for people with pancreatic cysts.

Who may be eligible for this pancreatic cyst clinical trial?

Adults aged 50 to 75 with pancreatic cysts at least 1 cm in size found in recent imaging may be eligible. Participants should not have a history of pancreatitis, pancreatic cancer, or pancreatic surgery, and must not have a family history of pancreatic adenocarcinoma. This trial includes all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this pancreatic cyst clinical trial?

Study-related care, including imaging tests, blood sample collection, and all trial visits, is provided at no cost. Personal travel and other expenses can vary and may not be covered by the study.

Actively Recruiting

Age: 50Years - 75Years

All Genders

ID04239573

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

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

Age: 50Years - 75Years

All Genders

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...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment including prior imaging review

Surveillance

Duration - Up to 5 years

Participants undergo imaging and optional blood sample collection to monitor pancreatic cysts as part of their assigned surveillance intensity.

Visits vary by surveillance arm: Arm A involves MRI, CT, or EUS at baseline and 1 year, then MRI or CT every 1 to 2 years; Arm B includes MRI, CT, or EUS at baseline with imaging every 3 to 24 months depending on cyst size and findings

Optional Diagnostic Procedures

Duration - Up to 5 years

Participants may undergo biopsy, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA), and surgery as clinically indicated during the trial.

Procedures occur as needed based on clinical findings; visit frequency varies

Long-term Monitoring

Duration - Up to 5 years

Participants are followed up every 6 months or yearly for up to 5 years from registration to assess outcomes including imaging findings, quality of life, anxiety, and financial distress.

Follow-up visits every 6 to 12 months

Trial Site Locations

Total: 424 locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

Actively Recruiting

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States, 36688

Actively Recruiting

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Suspended

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