Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

Status: Active_not_recruiting
Location: See all (352) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
University of South Alabama Mitchell Cancer Institute
Mobile
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Mayo Clinic in Arizona
Scottsdale
California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Enloe Medical Center
Chico
UC San Diego Health System - Encinitas
Encinitas
UC San Diego Moores Cancer Center
La Jolla
Loma Linda University Medical Center
Loma Linda
Veterans Affairs Loma Linda Healthcare System
Loma Linda
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles
University of California Davis Comprehensive Cancer Center
Sacramento
UC San Diego Medical Center - Hillcrest
San Diego
UCSF Medical Center-Mission Bay
San Francisco
UCSF Medical Center-Mount Zion
San Francisco
UCSF Medical Center-Parnassus
San Francisco
Connecticut
Smilow Cancer Hospital-Derby Care Center
Derby
Smilow Cancer Hospital Care Center-Fairfield
Fairfield
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury
Smilow Cancer Hospital Care Center at Greenwich
Greenwich
Smilow Cancer Hospital Care Center - Guilford
Guilford
Smilow Cancer Hospital-Hamden Care Center
Hamden
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Smilow Cancer Center/Yale-New Haven Hospital
New Haven
Yale University
New Haven
Yale-New Haven Hospital Saint Raphael Campus
New Haven
Yale-New Haven Hospital North Haven Medical Center
North Haven
Smilow Cancer Hospital-Orange Care Center
Orange
Smilow Cancer Hospital-Torrington Care Center
Torrington
Smilow Cancer Hospital Care Center-Trumbull
Trumbull
Smilow Cancer Hospital-Waterbury Care Center
Waterbury
Smilow Cancer Hospital Care Center - Waterford
Waterford
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven
Washington, D.c.
MedStar Georgetown University Hospital
Washington
Florida
Regional Cancer Center-Lee Memorial Health System
Fort Myers
Mayo Clinic in Florida
Jacksonville
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Iowa
Mission Cancer and Blood - Ankeny
Ankeny
Mercy Cancer Center-West Lakes
Clive
Mission Cancer and Blood - West Des Moines
Clive
Greater Regional Medical Center
Creston
Mercy Medical Center - Des Moines
Des Moines
Mission Cancer and Blood - Laurel
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Mercy Medical Center-West Lakes
West Des Moines
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Saint Luke's Cancer Institute - Fruitland
Fruitland
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Luke's Cancer Institute - Nampa
Nampa
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
Advocate Good Shepherd Hospital
Barrington
Bromenn Lifecare Center
Bloomington
Illinois CancerCare-Bloomington
Bloomington
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
SIH Cancer Institute
Carterville
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
Advocate Illinois Masonic Medical Center
Chicago
Northwestern University
Chicago
AMG Crystal Lake - Oncology
Crystal Lake
Carle at The Riverfront
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Northwestern Medicine Cancer Center Kishwaukee
Dekalb
Illinois CancerCare-Dixon
Dixon
Advocate Good Samaritan Hospital
Downers Grove
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Advocate Sherman Hospital
Elgin
Elmhurst Memorial Hospital
Elmhurst
Illinois CancerCare-Eureka
Eureka
NorthShore University HealthSystem-Evanston Hospital
Evanston
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Glenview
Ingalls Memorial Hospital
Harvey
Advocate South Suburban Hospital
Hazel Crest
NorthShore University HealthSystem-Highland Park Hospital
Highland Park
Illinois CancerCare-Kewanee Clinic
Kewanee
Northwestern Medicine Lake Forest Hospital
Lake Forest
AMG Libertyville - Oncology
Libertyville
Condell Memorial Hospital
Libertyville
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Edward Hospital/Cancer Center
Naperville
Bromenn Regional Medical Center
Normal
Carle Cancer Institute Normal
Normal
Cancer Care Center of O'Fallon
O'fallon
HSHS Saint Elizabeth's Hospital
O'fallon
Advocate Christ Medical Center
Oak Lawn
Northwestern Medicine Orland Park
Orland Park
Illinois CancerCare-Ottawa Clinic
Ottawa
Advocate Lutheran General Hospital
Park Ridge
Illinois CancerCare-Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Edward Hospital/Cancer Center?Plainfield
Plainfield
Illinois CancerCare-Princeton
Princeton
Memorial Medical Center
Springfield
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Southwest Illinois Health Services LLP
Swansea
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Illinois CancerCare - Washington
Washington
Indiana
Reid Health
Richmond
Louisiana
LSU Health Baton Rouge-North Clinic
Baton Rouge
Mary Bird Perkins Cancer Center
Baton Rouge
Our Lady of The Lake
Baton Rouge
Our Lady of the Lake Physician Group
Baton Rouge
Maryland
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Bronson Battle Creek
Battle Creek
Corewell Health Dearborn Hospital
Dearborn
Corewell Health Farmington Hills Hospital
Farmington Hills
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids
Trinity Health Grand Rapids Hospital
Grand Rapids
Ascension Borgess Cancer Center
Kalamazoo
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Trinity Health Muskegon Hospital
Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores
Corewell Health Reed City Hospital
Reed City
Cancer Care Associates PC
Royal Oak
Comprehensive Medical Center PLLC
Royal Oak
Corewell Health William Beaumont University Hospital
Royal Oak
Hematology Oncology Consultants PC
Royal Oak
Oakland Colon Rectal Associates
Royal Oak
Oakland Medical Group
Royal Oak
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph
Munson Medical Center
Traverse City
Corewell Health Beaumont Troy Hospital
Troy
Hematology Oncology Consultants PC-Troy
Troy
Michigan Institute of Urology-Town Center
Troy
University of Michigan Health - West
Wyoming
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Mayo Clinic in Rochester
Rochester
Sanford Thief River Falls Medical Center
Thief River Falls
Sanford Cancer Center Worthington
Worthington
Missouri
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
Parkland Health Center - Farmington
Farmington
MU Health Care Goldschmidt Cancer Center
Jefferson City
Missouri Baptist Medical Center
Saint Louis
Washington University School of Medicine
Saint Louis
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
Missouri Baptist Sullivan Hospital
Sullivan
BJC Outpatient Center at Sunset Hills
Sunset Hills
Montana
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Durham VA Medical Center
Durham
East Carolina University
Greenville
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Medical Center Fargo
Fargo
Sanford Roger Maris Cancer Center
Fargo
Sanford South University Medical Center
Fargo
Southpointe-Sanford Medical Center Fargo
Fargo
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon
New Jersey
CentraState Medical Center
Freehold
Morristown Medical Center
Morristown
Saint Peter's University Hospital
New Brunswick
Capital Health Medical Center-Hopewell
Pennington
Penn Medicine Princeton Health
Plainsboro
Overlook Hospital
Summit
New Mexico
University of New Mexico Cancer Center
Albuquerque
New York
Montefiore Medical Center - Moses Campus
Bronx
Montefiore Medical Center-Einstein Campus
Bronx
Montefiore Medical Center-Weiler Hospital
Bronx
Roswell Park Cancer Institute
Buffalo
Glens Falls Hospital
Glens Falls
Northwell Health/Center for Advanced Medicine
Lake Success
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Lenox Hill Hospital
New York
Stony Brook University Medical Center
Stony Brook
Ohio
Indu and Raj Soin Medical Center
Beavercreek
Saint Elizabeth Boardman Hospital
Boardman
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Oncology Hematology Care Inc-Kenwood
Cincinnati
MetroHealth Medical Center
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Dayton Physician LLC - Englewood
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Armes Family Cancer Center
Findlay
Blanchard Valley Hospital
Findlay
Orion Cancer Care
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Dayton Physicians LLC-Atrium
Franklin
Dayton Physicians LLC-Wayne
Greenville
Wayne Hospital
Greenville
Greater Dayton Cancer Center
Kettering
Kettering Medical Center
Kettering
Springfield Regional Cancer Center
Springfield
Springfield Regional Medical Center
Springfield
Dayton Physicians LLC - Troy
Troy
Upper Valley Medical Center
Troy
Saint Joseph Warren Hospital
Warren
Saint Elizabeth Youngstown Hospital
Youngstown
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Saint Charles Health System
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Clackamas Radiation Oncology Center
Clackamas
Providence Cancer Institute Clackamas Clinic
Clackamas
Bay Area Hospital
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Providence Newberg Medical Center
Newberg
Providence Willamette Falls Medical Center
Oregon City
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Saint Charles Health System-Redmond
Redmond
Pennsylvania
Saint Luke's Cancer Center - Allentown
Allentown
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem
Bryn Mawr Hospital
Bryn Mawr
Main Line Health Center-Collegeville
Collegeville
Geisinger Medical Center
Danville
Saint Luke's Hospital-Anderson Campus
Easton
Main Line Health Center-Exton
Exton
Riddle Memorial Hospital
Media
Paoli Memorial Hospital
Paoli
Fox Chase Cancer Center
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Philadelphia
Saint Luke's Hospital - Upper Bucks Campus
Quakertown
Saint Luke's Hospital-Quakertown Campus
Quakertown
Saint Luke's Hospital - Monroe Campus
Stroudsburg
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
Lankenau Medical Center
Wynnewood
Rhode Island
Smilow Cancer Hospital Care Center - Westerly
Westerly
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Bon Secours Saint Francis Hospital
Charleston
Roper Hospital
Charleston
Prisma Health Cancer Institute - Laurens
Clinton
Prisma Health Baptist Hospital
Columbia
Prisma Health Richland Hospital
Columbia
Prisma Health Cancer Institute - Easley
Easley
Tidelands Georgetown Memorial Hospital
Georgetown
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Greenville Memorial Hospital
Greenville
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
University of Tennessee - Knoxville
Knoxville
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
University of Texas Health Science Center at San Antonio
San Antonio
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
Virginia
Inova Alexandria Hospital
Alexandria
University of Virginia Cancer Center
Charlottesville
Inova Fair Oaks Hospital
Fairfax
Inova Schar Cancer Institute
Fairfax
Inova Fairfax Hospital
Falls Church
Inova Loudoun Hospital
Leesburg
Sentara Norfolk General Hospital
Norfolk
VCU Massey Cancer Center at Stony Point
Richmond
Virginia Commonwealth University/Massey Cancer Center
Richmond
Carilion Roanoke Memorial Hospital
Roanoke
Valley Health / Winchester Medical Center
Winchester
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont and State Agricultural College
Burlington
University of Vermont Medical Center
Burlington
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
PeaceHealth Saint Joseph Medical Center
Bellingham
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Providence Regional Cancer Partnership
Everett
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Providence Regional Cancer System-Lacey
Lacey
PeaceHealth Saint John Medical Center
Longview
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
Virginia Mason Medical Center
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Providence Regional Cancer System-Shelton
Shelton
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Aurora Saint Luke's South Shore
Cudahy
Marshfield Medical Center-EC Cancer Center
Eau Claire
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Mercyhealth Hospital and Cancer Center - Janesville
Janesville
Aurora Cancer Care-Kenosha South
Kenosha
Gundersen Lutheran Medical Center
La Crosse
University of Wisconsin Carbone Cancer Center - University Hospital
Madison
Aurora Bay Area Medical Group-Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Marshfield Medical Center-Rice Lake
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Medical Center - Weston
Weston
West Virginia
United Hospital Center
Bridgeport
WVUH-Berkely Medical Center
Martinsburg
West Virginia University Healthcare
Morgantown
Camden Clark Medical Center
Parkersburg
Other Locations
Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
Kingston Health Sciences Centre
Kingston
Royal Columbian Hospital
New Westminster
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto
Puerto Rico
Cancer Center-Metro Medical Center Bayamon
Bayamon
HIMA San Pablo Oncologic Hospital
Caguas
Doctors Cancer Center
Manati
Instituto Oncologia Moderna Ponce
Ponce
Centro Comprensivo de Cancer de UPR
San Juan
Primary Care Physician Group
San Juan
PROncology
San Juan
San Juan City Hospital
San Juan
San Juan Community Oncology Group
San Juan
Republic of Korea
National Cancer Center-Korea
Goyang-si
Yonsei University Health System-Severance Hospital
Seoul
Time Frame
Start Date: 2020-06-16
Completion Date: 2037-06-03
Participants
Target number of participants: 4606
Treatments
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 EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years.
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, 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.
Related Therapeutic Areas
Sponsors
Leads: ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov