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RECRUITING

NCT04239573

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

Sponsor: ECOG-ACRIN Cancer Research Group

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

770

Start Date

2020-06-16

Completion Date

2034-11-11

Last Updated

2026-09-04

Healthy Volunteers

Conditions

Pancreatic Neoplasm

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

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.

Locations (429)

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