Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT scan
    • tomography
  • Procedure: Endoscopic Ultrasound
    Undergo EUS
    Other names:
    • endosonography
    • EUS
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • 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, 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.
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT scan
    • tomography
  • Procedure: Endoscopic Ultrasound
    Undergo EUS
    Other names:
    • endosonography
    • EUS
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
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University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36688
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Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
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Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
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Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
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Alaska Women's Cancer Care
Anchorage, Alaska 99508
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Katmai Oncology Group
Anchorage, Alaska 99508
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Providence Alaska Medical Center
Anchorage, Alaska 99508
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Mayo Clinic Hospital in Arizona
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Providence Saint Joseph Medical Center/Disney Family Cancer Center
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UC San Diego Moores Cancer Center
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Advocate Outpatient Center - Aurora
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Barrington, Illinois 60010
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Carle BroMenn Outpatient Center
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Illinois CancerCare-Canton
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Memorial Hospital of Carbondale
Carbondale, Illinois 62902
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SIH Cancer Institute
Carterville, Illinois 62918
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Illinois CancerCare-Carthage
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Centralia Oncology Clinic
Centralia, Illinois 62801
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Northwestern University
Chicago, Illinois 60611
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Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
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AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
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Carle at The Riverfront
Danville, Illinois 61832
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Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
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Decatur Memorial Hospital
Decatur, Illinois 62526
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Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
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Illinois CancerCare-Dixon
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Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
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Carle Physician Group-Effingham
Effingham, Illinois 62401
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Crossroads Cancer Center
Effingham, Illinois 62401
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Advocate Sherman Hospital
Elgin, Illinois 60123
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Elmhurst Memorial Hospital
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Illinois CancerCare-Eureka
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Illinois CancerCare-Galesburg
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Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
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Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
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Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
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AMG Libertyville - Oncology
Libertyville, Illinois 60048
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Condell Memorial Hospital
Libertyville, Illinois 60048
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Illinois CancerCare-Macomb
Macomb, Illinois 61455
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Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
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Edward Hospital/Cancer Center
Naperville, Illinois 60540
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630-646-6075

Carle BroMenn Medical Center
Normal, Illinois 61761
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Carle Cancer Institute Normal
Normal, Illinois 61761
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Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
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HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
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Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
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Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
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Northwestern Medicine Orland Park
Orland Park, Illinois 60462
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Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
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Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
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Illinois CancerCare-Pekin
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Illinois CancerCare-Peoria
Peoria, Illinois 61615
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Methodist Medical Center of Illinois
Peoria, Illinois 61636
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Illinois CancerCare-Peru
Peru, Illinois 61354
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Valley Radiation Oncology
Peru, Illinois 61354
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Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois 60585
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Illinois CancerCare-Princeton
Princeton, Illinois 61356
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Southern Illinois University School of Medicine
Springfield, Illinois 62702
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Springfield Clinic
Springfield, Illinois 62702
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Springfield Memorial Hospital
Springfield, Illinois 62781
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Carle Cancer Center
Urbana, Illinois 61801
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The Carle Foundation Hospital
Urbana, Illinois 61801
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Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
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Illinois CancerCare - Washington
Washington, Illinois 61571
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Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
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UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
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Mercy Cancer Center-West Lakes
Clive, Iowa 50325
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
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Greater Regional Medical Center
Creston, Iowa 50801
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Iowa Methodist Medical Center
Des Moines, Iowa 50309
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UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
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Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
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UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
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University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
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800-237-1225

UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
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Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
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LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
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225-765-7659
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Our Lady of the Lake Physician Group
Baton Rouge, Louisiana 70808
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225-765-7659
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Our Lady of The Lake
Baton Rouge, Louisiana 70808
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Christiana Care - Union Hospital
Elkton, Maryland 21921
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410-443-1360
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MyMichigan Medical Center Gratiot
Alma, Michigan 48801
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MyMichigan Medical Center Alpena
Alpena, Michigan 49707
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
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800-865-1125
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Bronson Battle Creek
Battle Creek, Michigan 49017
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616-391-1230
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
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Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
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Trinity Health Medical Center - Canton
Canton, Michigan 48188
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Chelsea Hospital
Chelsea, Michigan 48118
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734-712-7251
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
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734-712-7251
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Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
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Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
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Corewell Health Dearborn Hospital
Dearborn, Michigan 48124
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248-551-7695

Henry Ford Health Saint John Hospital
Detroit, Michigan 48236
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313-343-3166
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Henry Ford River District Hospital
East China Township, Michigan 48054
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313-343-3166
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Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan 48336
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248-551-7695

Cancer Hematology Centers - Flint
Flint, Michigan 48503
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810-762-8038
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Genesee Hematology Oncology PC
Flint, Michigan 48503
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810-762-8038
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Genesys Hurley Cancer Institute
Flint, Michigan 48503
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810-762-8038
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Hurley Medical Center
Flint, Michigan 48503
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810-762-8038
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MyMichigan Medical Center Gladwin
Gladwin, Michigan 48624
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989-631-2469
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Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
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616-391-1230
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
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616-391-1230
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Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
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616-391-1230
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Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan 48236
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313-343-3166
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Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan 48236
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313-343-3166
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Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan 48236
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313-343-3166
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Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan 49009
Contact:
Site Public Contact
574-647-7370

Beacon Kalamazoo
Kalamazoo, Michigan 49048
Contact:
Site Public Contact
574-647-7370

University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan 48044
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan 48044
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

MyMichigan Medical Center Midland
Midland, Michigan 48670
Contact:
Site Public Contact
989-631-2469
CVResearch@mymichigan.org

MyMichigan Medical Center Mount Pleasant
Mount Pleasant, Michigan 48858
Contact:
Site Public Contact
989-631-2469
CVResearch@mymichigan.org

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Hope Cancer Center
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Oakland Colon Rectal Associates
Royal Oak, Michigan 48067
Contact:
Site Public Contact
248-551-7695

Cancer Care Associates PC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Comprehensive Medical Center PLLC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Corewell Health William Beaumont University Hospital
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Hematology Oncology Consultants PC-Royal Oak
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Oakland Medical Group
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

MyMichigan Medical Center Tawas
Tawas City, Michigan 48764
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Michigan Institute of Urology-Town Center
Troy, Michigan 48084
Contact:
Site Public Contact
248-551-7695

Corewell Health Beaumont Troy Hospital
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695

Hematology Oncology Consultants PC-Troy
Troy, Michigan 48098
Contact:
Site Public Contact
248-551-7695

Henry Ford Health Warren Hospital
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

Henry Ford Madison Heights Hospital - Breast
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

Henry Ford Warren Hospital - GLCMS
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015

Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
Contact:
Site Public Contact
605-312-3320

Sanford Cancer Center Worthington
Worthington, Minnesota 56187
Contact:
Site Public Contact
605-312-3320

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
St Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Contact:
Site Public Contact
406-327-3118
amy.hanneman@providence.org

CentraState Medical Center
Freehold, New Jersey 07728
Contact:
Site Public Contact
732-303-5047

Morristown Medical Center
Morristown, New Jersey 07960
Contact:
Site Public Contact
973-971-5900

Saint Peter's University Hospital
New Brunswick, New Jersey 08901
Contact:
Site Public Contact
732-745-8600
kcovert@saintpetersuh.com

Penn Medicine Princeton Health
Plainsboro, New Jersey 08536
Contact:
Site Public Contact
215-349-8245
PMCancerResearch@pennmedicine.upenn.edu

Overlook Hospital
Summit, New Jersey 07902
Contact:
Site Public Contact
908-522-2043

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Glens Falls Hospital
Glens Falls, New York 12801
Contact:
Site Public Contact
518-926-6700

Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896

Lenox Hill Hospital
New York, New York 10075
Contact:
Site Public Contact
516-734-8896

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
The Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Durham VA Medical Center
Durham, North Carolina 27705
Contact:
Site Public Contact
919-286-0411
VHADURcancertrials@va.gov

East Carolina University
Greenville, North Carolina 27834
Contact:
Site Public Contact
252-744-1015
eubankss@ecu.edu

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford South University Medical Center
Fargo, North Dakota 58103
Contact:
Site Public Contact
701-234-6161

Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota 58103
Contact:
Site Public Contact
605-312-3320

Sanford Medical Center Fargo
Fargo, North Dakota 58104
Contact:
Site Public Contact
800-437-4010

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon 97814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Charles Health System
Bend, Oregon 97701
Contact:
Site Public Contact
541-706-2909
nosall@stcharleshealthcare.org

Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Bay Area Hospital
Coos Bay, Oregon 97420
Contact:
Site Public Contact
541-269-8392
cherie.cox@bayareahospital.org

Providence Hood River Memorial Hospital
Hood River, Oregon 97031
Contact:
Site Public Contact
503-215-1979
canrsrchstudies@provdience.org

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu

Saint Charles Health System-Redmond
Redmond, Oregon 97756
Contact:
Site Public Contact
541-706-2909

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania 18104
Contact:
Site Public Contact
610-776-4714

Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
Contact:
Site Public Contact
484-503-4151

Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania 18045
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Riddle Memorial Hospital
Media, Pennsylvania 19063
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
Contact:
Site Public Contact
215-349-8245
PMCancerResearch@pennmedicine.upenn.edu

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania 18951
Contact:
Site Public Contact
610-776-4714

Saint Luke's Hospital - Monroe Campus
Stroudsburg, Pennsylvania 18360
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island 02891
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Roper Hospital
Charleston, South Carolina 29401
Contact:
Site Public Contact
843-724-2466
Julia.Johnson@rsfh.com

Bon Secours Saint Francis Hospital
Charleston, South Carolina 29414
Contact:
Site Public Contact
843-724-2466
Julia.Johnson@rsfh.com

Prisma Health Richland Hospital
Columbia, South Carolina 29203
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-4317
Kim.Williams3@prismahealth.org

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

University of Tennessee - Knoxville
Knoxville, Tennessee 37920
Contact:
Site Public Contact
865-544-9773

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
713-798-1354
burton@bcm.edu

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont 05602
Contact:
Site Public Contact
802-225-5400

University of Vermont Medical Center
Burlington, Vermont 05401
Contact:
Site Public Contact
802-656-4101
rpo@uvm.edu

University of Vermont and State Agricultural College
Burlington, Vermont 05405
Contact:
Site Public Contact
802-656-8990
rpo@uvm.edu

Inova Alexandria Hospital
Alexandria, Virginia 22304
Contact:
Site Public Contact
703-776-2580
Stephanie.VanBebber@inova.org

University of Virginia Cancer Center
Charlottesville, Virginia 22908
Contact:
Site Public Contact
434-243-6303
uvacancertrials@hscmail.mcc.virginia.edu

Inova Schar Cancer Institute
Fairfax, Virginia 22031
Contact:
Site Public Contact
703-720-5210
Stephanie.VanBebber@inova.org

Inova Fair Oaks Hospital
Fairfax, Virginia 22033
Contact:
Site Public Contact
703-720-5210
Stephanie.VanBebber@inova.org

Inova Fairfax Hospital
Falls Church, Virginia 22042
Contact:
Site Public Contact
703-208-6650
Stephanie.VanBebber@inova.org

Inova Loudoun Hospital
Leesburg, Virginia 20176
Contact:
Site Public Contact
703-858-6000
Keary.janet@inova.org

Sentara Norfolk General Hospital
Norfolk, Virginia 23507
Contact:
Site Public Contact
757-388-2406

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
804-628-6430
CTOclinops@vcu.edu

Valley Health / Winchester Medical Center
Winchester, Virginia 22601
Contact:
Site Public Contact
540-536-7820

Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
Contact:
Site Public Contact
360-412-8958
deidre.dillon@providence.org

PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Contact:
Site Public Contact
360-788-8223
achapman1@peacehealth.org

Providence Regional Cancer System-Centralia
Centralia, Washington 98531
Contact:
Site Public Contact
360-412-8958
deidre.dillon@providence.org

Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

Providence Regional Cancer Partnership
Everett, Washington 98201
Contact:
Site Public Contact
425-261-3529
marilyn.birchman@providence.org

Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
Contact:
Site Public Contact
509-783-4637
research@kadlecmed.org

Providence Regional Cancer System-Lacey
Lacey, Washington 98503
Contact:
Site Public Contact
360-412-8958
deidre.dillon@providence.org

PeaceHealth Saint John Medical Center
Longview, Washington 98632
Contact:
Site Public Contact
360-514-2016
kmakin-bond@peacehealth.org

Skagit Regional Health Cancer Care Center
Mount Vernon, Washington 98274
Contact:
Site Public Contact
360-814-2182
rcccclinicalresearch@skagitvalleyhospital.org

Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
Contact:
Site Public Contact
206-215-3086
PCRC-NCORP@Swedish.org

Swedish Medical Center-First Hill
Seattle, Washington 98122
Contact:
Site Public Contact
206-215-2343
PCRC-NCORP@Swedish.org

PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
Contact:
Site Public Contact
360-788-8239
achapman1@peacehealth.org

Cancer Care Northwest - Spokane South
Spokane, Washington 99202
Contact:
Site Public Contact
509-228-1680
research@ccnw.net

Cancer Care Northwest-Valley
Spokane, Washington 99216
Contact:
Site Public Contact
509-228-1680
research@ccnw.net

Cancer Care Northwest-North Spokane
Spokane, Washington 99218
Contact:
Site Public Contact
509-228-1680
research@ccnw.net

PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Contact:
Site Public Contact
360-514-3940
kmakin-bond@peacehealth.org

Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
Contact:
Site Public Contact
509-897-5993
Cheryl.Dodd@providence.org

West Virginia University Healthcare
Morgantown, West Virginia 26506
Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu

Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's South Shore
Cudahy, Wisconsin 53110
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Cancer Center-Metro Medical Center Bayamon
Bayamón, Puerto Rico 00959-5060
Contact:
Site Public Contact
787-395-7085

Puerto Rico Hematology Oncology Group
Bayamón, Puerto Rico 00961
Contact:
Site Public Contact
787-780-2865

Doctors Cancer Center
Manati, Puerto Rico 00674
Contact:
Site Public Contact
787-621-4397

San Juan Community Oncology Group
San Juan, Puerto Rico 00917
Contact:
Site Public Contact
787-274-3387

Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

PROncology
San Juan, Puerto Rico 00927
Contact:
Site Public Contact
787-919-7919
info@PRoncology.com

San Juan City Hospital
San Juan, Puerto Rico 00936
Contact:
Site Public Contact
787-763-1296

More Details

NCT ID
NCT04239573
Status
Recruiting
Sponsor
ECOG-ACRIN Cancer Research Group

Detailed Description

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 .

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