RecruitingNCT04239573

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

Sponsor

ECOG-ACRIN Cancer Research Group

Enrollment

770 participants

Start Date

Jun 16, 2020

Study Type

OBSERVATIONAL

Conditions

Pancreatic Neoplasm

Summary

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.

Eligibility

Min Age: 50 YearsMax Age: 75 Years

Inclusion Criteria21

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.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEndoscopic Ultrasound

Undergo EUS

PROCEDUREEndoscopic Ultrasound-Guided Fine-Needle Aspiration

Undergo EUS-FNA

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERQuality-of-Life Assessment

Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)

OTHERQuestionnaire Administration

Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)

PROCEDURESurgical Procedure

Undergo surgery

Locations(424)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Anchorage Associates in Radiation Medicine