Comparing Two Methods To Follow Patients With Pancreatic Cysts

Study Overview

Comparing Two Methods to Follow Patients With Pancreatic Cysts

The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts.

PRIMARY OBJECTIVES: I. To compare the rates of unfavorable clinical outcomes in the two arms. SECONDARY OBJECTIVES: I. To compare rates of major surgical morbidity and/or mortality between arms. II. To compare pancreatic cancer incidence and all-cause mortality across arms. III. Compare institutional (direct) costs. IV. Compare healthcare utilization of imaging, invasive testing, surgical, and other procedures across the two surveillance arms. V. Compare patient (out-of-pocket and other indirect) costs. VI. Describe diagnostic test and treatment pathways by arm. VII. Compare patient reports of quality of life (QOL), situational anxiety. VIII. Compare patient report of financial distress. IX. Compare rates of non-adherence by arm assignment. X. To evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer. EXPLORATORY OBJECTIVE: I. To evaluate and compare the predictive accuracy of known and future radiomic markers for dysplasia and pancreatic cancer. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (LOW INTENSITY SURVEILLANCE): Patients undergo magnetic resonance imaging (MRI) or computed tomography (CT) at the beginning of the trial and again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative endoscopic ultrasound (EUS), repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. ARM B (HIGH INTENSITY SURVEILLANCE): Patients undergo MRI or CT. Patients with 1-2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with 2-3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst > 3 cm undergo EUS within 6 months, and if EUS is negative, patients undergo alternate MRI or CT with EUS every 3-6 months. After completion of imaging procedures, patients are followed up for 5 years from the date of registration .

Pancreatic Carcinoma

PROCEDURE: Computed Tomography
PROCEDURE: Endoscopic Ultrasound
PROCEDURE: Magnetic Resonance Imaging
OTHER: Quality-of-Life Assessment
OTHER: Questionnaire Administration

EA2185
NCI-2019-04790 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
EA2185 (OTHER Identifier) (OTHER: ECOG-ACRIN Cancer Research Group)
ECOG-ACRIN-EA2185 (OTHER Identifier) (OTHER: DCP)
EA2185 (OTHER Identifier) (OTHER: CTEP)
UG1CA189828 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-01-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-04
First Submitted that Met QC Criteria 2020-01-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-08
First Posted (ACTUAL) 2020-01-27	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm I (low intensity surveillance) Patients undergo MRI or CT at the beginning of the trial and again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative	PROCEDURE: Computed Tomography Undergo CT PROCEDURE: Endoscopic Ultrasound Undergo EUS PROCEDURE: Magnetic Resonance Imaging Undergo MRI OTHER: Quality-of-Life Assessment Ancillary studies OTHER: Questionnaire Administration Ancillary studies
EXPERIMENTAL: Arm II (high intensity surveillance) Patients undergo MRI or CT. Patients with 1-2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with 2-3 cm cyst undergo EUS within 6 months, and if EUS is negative, patien	PROCEDURE: Computed Tomography Undergo CT PROCEDURE: Endoscopic Ultrasound Undergo EUS PROCEDURE: Magnetic Resonance Imaging Undergo MRI OTHER: Quality-of-Life Assessment Ancillary studies OTHER: Questionnaire Administration Ancillary studies

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm I (low intensity surveillance)

Patients undergo MRI or CT at the beginning of the trial and again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative

PROCEDURE: Computed Tomography

Undergo CT

PROCEDURE: Endoscopic Ultrasound

Undergo EUS

PROCEDURE: Magnetic Resonance Imaging

Undergo MRI

OTHER: Quality-of-Life Assessment

Ancillary studies

OTHER: Questionnaire Administration

Ancillary studies

EXPERIMENTAL: Arm II (high intensity surveillance)

Patients undergo MRI or CT. Patients with 1-2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with 2-3 cm cyst undergo EUS within 6 months, and if EUS is negative, patien

PROCEDURE: Computed Tomography

Undergo CT

PROCEDURE: Endoscopic Ultrasound

Undergo EUS

PROCEDURE: Magnetic Resonance Imaging

Undergo MRI

OTHER: Quality-of-Life Assessment

Ancillary studies

OTHER: Questionnaire Administration

Ancillary studies

Primary Outcome Measures	Measure Description	Time Frame
Occurrence of an "unfavorable" outcome	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 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.	Up to 5 years

Secondary Outcome Measures	Measure Description	Time Frame
Surgical and all-cause mortality	Rates of major surgical morbidity and/or mortality will be estimated and compared across arms. All-cause mortality will be estimated and compared between the arms using log rank tests.	Up to 5 years
Major surgical morbidity	Rates of major surgical morbidity and/or mortality will be estimated and compared across arms.	Up to 5 years
Pancreatic cancer incidence	Pancreatic-cancer incidence and pancreatic cancer specific mortality will be estimated and compared between the arms using log rank tests.	Up to 5 years
Healthcare utilization of imaging, invasive testing, surgical, and other procedures using information collected from sites.	Will compare between two arms.	Up to 5 years
Patient (out-of-pocket and other indirect) costs collected from patient surveys	Will compare between two arms.	Up to 5 years
Patient reports of quality of life	Will be assessed by Patient Reported Outcomes Measurement Information System10. Will compare between arms. Longitudinal regression modelling will be completed to account for the repeated assessments over time.	Up to 5 years
Patient reports of situational anxiety	Will be assessed by Patient Reported Outcomes Measurement Information System-Anxiety short form. Will compare between arms.	Up to 5 years
Patient report of financial distress collected through patient surveys	Will compare between arms.	Up to 5 years
Rates of non-adherence	Will compare rates of non-adherence by arm assignment.	Up to 5 years
Biomarker analysis from collected samples to compare the predictive performance of known and future biomarkers for dysplasia or cancer	Will evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.	Up to 5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
50 Years

Accepts Healthy Volunteers:

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 randomization 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 pancreatic cyst resection.
Patient must not be participating in any form of pancreatic cyst surveillance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: David S Weinberg, ECOG-ACRIN Cancer Research Group

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Weinberg DS, Gatsonis C, Zeh HJ, Carlos RC, O'Dwyer PJ; EA2185 Team. Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185). Contemp Clin Trials. 2020 Oct;97:106144. doi: 10.1016/j.cct.2020.106144. Epub 2020 Sep 10.

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