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Observational Study on Pancreatic Cyst Monitoring and Biomarkers

This observational study is looking at different ways to monitor pancreatic cysts and identify markers in the body (biomarkers) that could help detect when a cyst might become cancerous. Researchers want to compare more frequent monitoring with less frequent monitoring to see which approach leads to better patient outcomes. They also aim to find biomarkers that can improve the detection of risk. You may be able to join if you are between 50 and 75 years old, do not have acute or chronic pancreatitis, and have at least one pancreatic cyst of 1 cm or larger identified within the last six months. The study hopes to understand which monitoring methods and biomarkers are most effective over a period of up to five years.

Study design
This is an observational study planning to enroll 770 participants. It compares two approaches for monitoring pancreatic cysts.
What's involved
You may undergo procedures such as biopsy, blood sample collection, CT scans, EUS, and EUS-FNA. The study aims to follow participants for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to observe the development of worrisome features or unfavorable outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04239573

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

Recruiting
Not specifiedAges 50–75Observational
ECOG-ACRIN Cancer Research Group
~770 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyEndoscopic UltrasoundEndoscopic Ultrasound-Guided Fine-Needle AspirationMagnetic Resonance Imaging

At a glance

Recruiting sites
344 of 429 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)
Measured over Up to 5 years
+1 more outcome measured

Conditions

Pancreatic Neoplasm

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Pancreatic Neoplasm

Where it's being run

429 sites across 46 states
Michigan67
Illinois62
Wisconsin27
Ohio25
Washington24
Pennsylvania22
Connecticut17
South Carolina14

Study leadership

  • David S Weinberg · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group

Who to contact

Site Public Contact
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)Up to 5 years

    Will assess the predictive performance of both primary markers separately. Time to first occurrence of worrisome features and/or high-risk stigmata will be measured from the time of baseline blood draw. Will use an overall significance level of 0.1. Will use a Bonferroni correction for multiplicity adjustment, the significance level applied to both primary biomarkers will be 0.05. Will evaluate using a two-sided log-rank test comparing time to occurrence of worrisome features and/or high-risk stigmata between the marker-positive and marker-negative subgroups. Will visually summarize time to occurrence of worrisome features and/or high-risk stigmata in both maker positive and marker negative using Kaplan-Meier curves. All biomarkers will come in with a predetermined threshold for determining marker positivity (as defined in their respective publications). The primary imaging marker is for MRI, the analysis of this biomarker will be restricted to participants with a pre-enrollment MRI.

  • Occurrence of an "unfavorable" outcome (PRIOR TO ADDENDUM #5 08/13/2024)Up to 5 years

    Defined as a composite of: (1) any pancreatic cancer without surgery; (2) unresectable pancreatic cancer or cancer \> T1a, N0 at surgery, and (3) benign disease at surgery will be approached from the intent-to-treat perspective. Time to the first occurrence of the primary endpoint will be measured from randomization. Survival analysis methods will be used to estimate and compare distributions of time to an unfavorable event between the study arms. In particular Kaplan-Meier estimates will be developed for each arm and a log rank test will be used to compare the two arms.