Comparing two ways to monitor pancreatic cysts

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial assigns participants to either a lower-intensity surveillance schedule or a more frequent imaging schedule using MRI or CT, with endoscopic ultrasound (EUS) used when imaging shows concerning features. The primary outcome is the rate of unfavorable clinical outcomes between the two arms, and secondary outcomes include surgical morbidity/mortality, pancreatic cancer incidence, overall mortality, costs, healthcare utilization, quality of life, anxiety, financial distress, and non-adherence. The protocol includes comparison of known and future biomarkers and an exploratory analysis of radiomic markers to predict dysplasia or cancer. Eligible participants are adults 50–75 years old with at least one pancreatic cyst ≥1 cm on recent imaging and without high-risk features that would prompt immediate surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham Cancer Center
  Birmingham, Alabama, United States Recruiting
• University of South Alabama Mitchell Cancer Institute
  Mobile, Alabama, United States Recruiting
• Anchorage Associates in Radiation Medicine
  Anchorage, Alaska, United States Recruiting
• Alaska Breast Care and Surgery LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Oncology and Hematology LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Women's Cancer Care
  Anchorage, Alaska, United States Recruiting

+379 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David S Weinberg — ECOG-ACRIN Cancer Research Group

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.