NCT04239573 · ECOG-ACRIN Cancer Research Group
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
What this study is about
The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer.
View original scientific description
The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.
Interventions
PROCEDURE
Biopsy Procedure
Undergo biopsy
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Computed Tomography
Undergo CT
PROCEDURE
Endoscopic Ultrasound
Undergo EUS
PROCEDURE
Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Undergo EUS-FNA
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
OTHER
Quality-of-Life Assessment
Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)
OTHER
Questionnaire Administration
Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)
PROCEDURE
Surgical Procedure
Undergo surgery
Primary outcome measures
Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
- Mobile, Alabama
- Anchorage, Alaska
- Phoenix, Arizona
- Scottsdale, Arizona
- Little Rock, Arkansas
- Burbank, California
- Encinitas, California
- La Jolla, California
- Loma Linda, California
- Los Angeles, California
- Sacramento, California
And 285 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations