Pancreatic NeoplasmNCT04239573
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
An observational study of Pancreatic Neoplasm, run by ECOG-ACRIN Cancer Research Group at 429 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Computed Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 770 participants
- Where
- 429 sitesin 4 countries
- Study dates
- 16 Jun 2020to 11 Nov 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic cysts.
Who may be able to join
- 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
Show all 21Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
429 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
316 sites in 4 countries
United States300 sites, 241 recruiting
- Recruiting
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Matthew Hernandez
- Recruiting
Inova Alexandria Hospital
Alexandria, Virginia, 22304
Site Public Contact, 703-776-2580, Stephanie.VanBebber@inova.org
Peter Learn
- Recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania, 18104
Site Public Contact, 610-776-4714
Darius C. Desai
- Recruiting
MyMichigan Medical Center Gratiot
Alma, Michigan, 48801
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
MyMichigan Medical Center Alpena
Alpena, Michigan, 49707
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Suspended
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504
- Recruiting
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Suspended
Anchorage Oncology Centre
Anchorage, Alaska, 99508
- Recruiting
Katmai Oncology Group
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, 99508
Site Public Contact, 907-212-6871, AKPAMC.OncologyResearchSupport@providence.org
Alison K. Conlin
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Richard Kwon
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Saurabh Chawla
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Saurabh Chawla
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Saurabh Chawla
- Recruiting
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
Site Public Contact, ncorp@aah.org
Thomas J. Saphner
- Recruiting
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Site Public Contact, 847-842-4847
Thomas J. Saphner
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659, research@ololrmc.com
Marshall P. Stagg
- Recruiting
Our Lady of The Lake
Baton Rouge, Louisiana, 70808
Site Public Contact, 225-765-7659
Marshall P. Stagg
- Active, not recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Active, not recruiting
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431
- Recruiting
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Site Public Contact, 360-788-8223, achapman1@peacehealth.org
Alison K. Conlin
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Alison K. Conlin
- Recruiting
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Site Public Contact, 802-225-5400
Conor H. O'Neill
- Recruiting
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Site Public Contact, 484-503-4151
Darius C. Desai
- Recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Site Public Contact, gingerreeves@uabmc.edu
Samuel Galgano
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Carle BroMenn Outpatient Center
Bloomington, Illinois, 61704
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512
- Active, not recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Active, not recruiting
United Hospital Center
Bridgeport, West Virginia, 26330
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Site Public Contact, 484-476-2649, turzoe@mlhs.org
Paul B. Gilman
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Site Public Contact, 800-767-9355, askroswell@roswellpark.org
Tessa F. Flores
- Recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Site Public Contact, 818-847-4793, Najee.Boucher@providence.org
Alison K. Conlin
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Site Public Contact, 802-656-4101, rpo@uvm.edu
Conor H. O'Neill
- Recruiting
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Site Public Contact, 802-656-8990, rpo@uvm.edu
Conor H. O'Neill
- Recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
Site Public Contact, 618-457-5200, clinical.research@sih.net
Bryan A. Faller
- Recruiting
SIH Cancer Institute
Carterville, Illinois, 62918
Site Public Contact, 618-985-3333, clinical.research@sih.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
- Suspended
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Recruiting
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Jen J. Yeh
- Recruiting
Roper Hospital
Charleston, South Carolina, 29401
Site Public Contact, 843-724-2466, Julia.Johnson@rsfh.com
Daniel D. Kirchoff
- Recruiting
Bon Secours Saint Francis Hospital
Charleston, South Carolina, 29414
Site Public Contact, 843-724-2466, Julia.Johnson@rsfh.com
Daniel D. Kirchoff
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu
Todd W. Bauer
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Akhil Chawla
- Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Site Public Contact, 773-296-5360
Thomas J. Saphner
- Active, not recruiting
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Suspended
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015
- Recruiting
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Suspended
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346
- Active, not recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
- Active, not recruiting
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Suspended
Main Line Health Center-Collegeville
Collegeville, Pennsylvania, 19426
- Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Suspended
Prisma Health Baptist Hospital
Columbia, South Carolina, 29220
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Erica Park
- Recruiting
Bay Area Hospital
Coos Bay, Oregon, 97420
Site Public Contact, 541-269-8392, cherie.cox@bayareahospital.org
Alison K. Conlin
- Recruiting
Greater Regional Medical Center
Creston, Iowa, 50801
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Site Public Contact, 630-929-6129, advocateresearch@advocate.com
Thomas J. Saphner
- Recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Patricio M. Polanco
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu
Amitpal S. Johal
- Suspended
Miami Valley Hospital
Dayton, Ohio, 45409
- Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
- Suspended
Miami Valley Hospital North
Dayton, Ohio, 45415
- Recruiting
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Site Public Contact, 248-551-7695
Andrew A. Muskovitz
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Akhil Chawla
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Recruiting
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Site Public Contact, 515-241-6727
Seema Harichand-Herdt
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Site Public Contact, 313-343-3166, Kkeenan1@hfhs.org
Elie G. Dib
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Site Public Contact, 630-275-1270, Barbara.barhamand@advocatehealth.com
Thomas J. Saphner
- Recruiting
Durham VA Medical Center
Durham, North Carolina, 27705
Site Public Contact, 919-286-0411, VHADURcancertrials@va.gov
Michael Lidsky
- Active, not recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
- Recruiting
Henry Ford River District Hospital
East China, Michigan, 48054
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Active, not recruiting
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095
- Recruiting
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Recruiting
Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania, 18045
Site Public Contact, ecog.rss@jimmy.harvard.edu
Darius C. Desai
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Sabo B. Tanimu
- Recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Advocate Sherman Hospital
Elgin, Illinois, 60123
Site Public Contact, 847-429-2907
Thomas J. Saphner
- Recruiting
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Site Public Contact, 410-443-1360, frank.crum@christianacare.org
Gregory A. Masters
- Recruiting
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126
Site Public Contact, 630-758-5460, Jrohde@emhc.org
George I. Salti
- Suspended
UC San Diego Health System - Encinitas
Encinitas, California, 92024
- Recruiting
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Site Public Contact, 201-894-3456
Cherif N. Boutros
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Site Public Contact, 425-261-3529, marilyn.birchman@providence.org
Alison K. Conlin
- Suspended
Main Line Health Center-Exton
Exton, Pennsylvania, 19341
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Peter Learn
- Recruiting
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Peter Learn
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Peter Learn
- Recruiting
Sanford South University Medical Center
Fargo, North Dakota, 58103
Site Public Contact, 701-234-6161
Daniel Almquist
- Recruiting
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103
Site Public Contact, 605-312-3320
Daniel Almquist
- Recruiting
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
Site Public Contact, 800-437-4010
Daniel Almquist
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Parkland Health Center - Farmington
Farmington, Missouri, 63640
Site Public Contact, 314-996-5569
Bryan A. Faller
- Recruiting
Corewell Health Farmington Hills Hospital
Farmington Hills, Michigan, 48336
Site Public Contact, 248-551-7695
Andrew A. Muskovitz
- Active, not recruiting
Armes Family Cancer Center
Findlay, Ohio, 45840
- Active, not recruiting
Blanchard Valley Hospital
Findlay, Ohio, 45840
- Active, not recruiting
Orion Cancer Care
Findlay, Ohio, 45840
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Site Public Contact, eileen.georgi@holy-cross.com
Elie G. Dib
- Recruiting
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905
Site Public Contact, ecog.rss@jimmy.harvard.edu
Paul M. Bloomston
- Suspended
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
- Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
- Recruiting
CentraState Medical Center
Freehold, New Jersey, 07728
Site Public Contact, 732-303-5047
Alexander Itskovich
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Suspended
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Akhil Chawla
- Active, not recruiting
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, 29440
- Recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
MyMichigan Medical Center Gladwin
Gladwin, Michigan, 48624
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Active, not recruiting
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061
- Recruiting
Glens Falls Hospital
Glens Falls, New York, 12801
Site Public Contact, 518-926-6700
Conor H. O'Neill
- Active, not recruiting
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
- Recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Site Public Contact, 252-744-1015, eubankss@ecu.edu
Emmanuel E. Zervos
- Active, not recruiting
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
- Active, not recruiting
Wayne Hospital
Greenville, Ohio, 45331
- Active, not recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
- Active, not recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
- Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org
Ki Y. Chung
- Active, not recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Active, not recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
- Recruiting
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, karen.forman@ascension.org
Elie G. Dib
- Recruiting
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Recruiting
Smilow Cancer Hospital-Hamden Care Center
Hamden, Connecticut, 06518
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Recruiting
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Active, not recruiting
Ingalls Memorial Hospital
Harvey, Illinois, 60426
- Recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Site Public Contact, 708-799-9995
Thomas J. Saphner
- Recruiting
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201
Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org
Elie G. Dib
- Active, not recruiting
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
- Recruiting
University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina, 27278
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Jen J. Yeh
- Recruiting
Providence Hood River Memorial Hospital
Hood River, Oregon, 97031
Site Public Contact, 503-215-1979, canrsrchstudies@provdience.org
Alison K. Conlin
- Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Site Public Contact, 713-798-1354, burton@bcm.edu
George Van Buren
- Recruiting
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
Site Public Contact, 304-399-6566, Christina.Cole@chhi.org
Toni O. Pacioles
- Recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Site Public Contact, 317-278-5632, iutrials@iu.edu
Mohammad Al-Haddad
- Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Site Public Contact, 800-237-1225
James P. De Andrade
- Recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org
Alison K. Conlin
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Site Public Contact, 855-776-0015
Rahul Pannala
- Active, not recruiting
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548
- Suspended
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Site Public Contact, 574-647-7370
Kathleen Y. Butler
- Recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Site Public Contact, 509-783-4637, research@kadlecmed.org
Alison K. Conlin
- Recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Active, not recruiting
Greater Dayton Cancer Center
Kettering, Ohio, 45409
- Active, not recruiting
Kettering Medical Center
Kettering, Ohio, 45429
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920
Site Public Contact, 865-544-9773
Ryan K. Schmocker
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
Kurt Oettel
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Site Public Contact, 858-822-5354, cancercto@ucsd.edu
Rebekah R. White
- Recruiting
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503
Site Public Contact, 360-412-8958, deidre.dillon@providence.org
Alison K. Conlin
- Active, not recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Site Public Contact, 516-734-8896
Elliot Newman
- Recruiting
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, 33805
Site Public Contact, 863-904-1900
Kelly Koch
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Elie G. Dib
- Active, not recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
- Recruiting
Inova Loudoun Hospital
Leesburg, Virginia, 20176
Site Public Contact, 703-858-6000, Keary.janet@inova.org
Peter Learn
- Recruiting
Beebe Medical Center
Lewes, Delaware, 19958
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Thomas J. Saphner
- Recruiting
Condell Memorial Hospital
Libertyville, Illinois, 60048
Site Public Contact, 630-929-6129, advocateresearch@advocatehealth.com
Thomas J. Saphner
- Suspended
Baptist Health Medical Center - Little Rock
Little Rock, Arkansas, 72205
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Chad E. Cragle
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Site Public Contact, 909-558-4050
Mark E. Reeves
- Active, not recruiting
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, 92357
- Recruiting
PeaceHealth Saint John Medical Center
Longview, Washington, 98632
Site Public Contact, 360-514-2016, kmakin-bond@peacehealth.org
Alison K. Conlin
- Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
Site Public Contact, 888-798-0719
Timothy R. Donahue
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, 48044
Site Public Contact, 313-343-3166, kforman1@hfhs.org
Elie G. Dib
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Daniel E. Abbott
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Daniel E. Abbott
- Recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Sabo B. Tanimu
- Active, not recruiting
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Suparna Mantha
- Recruiting
Riddle Memorial Hospital
Media, Pennsylvania, 19063
Site Public Contact, 484-476-2649, turzoe@mlhs.org
Paul B. Gilman
- Active, not recruiting
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
- Recruiting
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
MyMichigan Medical Center Midland
Midland, Michigan, 48670
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Site Public Contact, 302-291-6730, research@beebehealthcare.org
Gregory A. Masters
- Recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Sabo B. Tanimu
- Recruiting
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Site Public Contact, 406-327-3118, amy.hanneman@providence.org
Alison K. Conlin
- Recruiting
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36688
Site Public Contact, 251-445-9870, pfrancisco@usouthal.edu
Joe S. Liles
- Active, not recruiting
West Virginia University Healthcare
Morgantown, West Virginia, 26506
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Site Public Contact, 973-971-5900
Kai A. Bickenbach
- Recruiting
MyMichigan Medical Center Mount Pleasant
Mount Pleasant, Michigan, 48858
Site Public Contact, 989-631-2469, CVResearch@mymichigan.org
Elie G. Dib
- Recruiting
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274
Site Public Contact, 360-814-2182, rcccclinicalresearch@skagitvalleyhospital.org
Alison K. Conlin
- Recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Alison K. Conlin
- Recruiting
Edward Hospital/Cancer Center
Naperville, Illinois, 60540
Site Public Contact, 630-646-6075
George I. Salti
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Marcus C. Tan
- Recruiting
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901
Site Public Contact, 732-745-8600 ext. 6163, kcovert@saintpetersuh.com
Arkady Broder
- Recruiting
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Recruiting
Yale-New Haven Hospital Saint Raphael Campus
New Haven, Connecticut, 06511
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Suspended
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
- Recruiting
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Site Public Contact, 212-434-4460
Elliot Newman
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Site Public Contact, 516-734-8896
Elliot Newman
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen Y. Butler
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Site Public Contact, 757-388-2406
Eric C. Feliberti
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Suparna Mantha
- Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Suspended
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Akhil Chawla
- Recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Site Public Contact, 800-323-8622
Thomas J. Saphner
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Ajay Jain
- Recruiting
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
Smilow Cancer Hospital-Orange Care Center
Orange, Connecticut, 06477
Site Public Contact, 203-785-5702, canceranswers@yale.edu
James J. Farrell
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Alison K. Conlin
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Akhil Chawla
- Recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Site Public Contact, 414-302-2304, ncorp@aurora.org
Thomas J. Saphner
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
Site Public Contact, 484-476-2649, turzoe@mlhs.org
Paul B. Gilman
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Site Public Contact, 847-384-3621
Thomas J. Saphner
- Active, not recruiting
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Capital Health Medical Center-Hopewell
Pennington, New Jersey, 08534
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Valley Radiation Oncology
Peru, Illinois, 61354
Site Public Contact, 815-664-4141
Bryan A. Faller
- Recruiting
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Site Public Contact, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Hanna Zafar
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Avinoam Nevler
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Site Public Contact, 215-728-4790
David S. Weinberg
- Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Site Public Contact, 855-776-0015
Rahul Pannala
- Recruiting
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585
Site Public Contact, 630-646-6075, Cancerresearch@edward.org
George I. Salti
- Suspended
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536
- Suspended
Hope Cancer Center
Pontiac, Michigan, 48341
Puerto Rico10 sites, 7 recruiting
- Recruiting
Cancer Center-Metro Medical Center Bayamon
Bayamón, 00959-5060
Site Public Contact, 787-395-7085
Luis J. Santos Reyes
- Recruiting
Puerto Rico Hematology Oncology Group
Bayamón, 00961
Site Public Contact, 787-780-2865
Luis J. Santos Reyes
- Suspended
HIMA San Pablo Oncologic Hospital
Caguas, 00726
- Recruiting
Doctors Cancer Center
Manati, 00674
Site Public Contact, 787-621-4397
Luis J. Santos Reyes
- Suspended
Instituto Oncologia Moderna Ponce
Ponce, 00716
- Recruiting
San Juan Community Oncology Group
San Juan, 00917
Site Public Contact, 787-274-3387
Luis J. Santos Reyes
- Suspended
Primary Care Physician Group
San Juan, 00920
- Recruiting
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Site Public Contact, ecog.rss@jimmy.harvard.edu
Luis J. Santos Reyes
- Recruiting
PROncology
San Juan, 00927
Site Public Contact, 787-919-7919, info@PRoncology.com
Luis J. Santos Reyes
- Recruiting
San Juan City Hospital
San Juan, 00936
Site Public Contact, 787-763-1296
Luis J. Santos Reyes
Canada4 sites
- Suspended
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
- Suspended
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
- Suspended
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
- Suspended
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
South Korea2 sites, 2 recruiting
- Recruiting
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, 410-769
Site Public Contact, 82-31-920-1934
Sang Myung Woo
- Recruiting
Yonsei University Health System-Severance Hospital
Seoul, 120-752
Site Public Contact, ihcc@yuhs.ac
Seungmin Bang
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate whether the protocol specified primary biomarkers (both blood and imaging-based) measured at baseline, are associated with the future development of worrisome features and/or high-risk stigmata.
SECONDARY OBJECTIVES:
- Evaluate whether the imaging-based secondary biomarker implemented using baseline computed tomography (CT) scans and/or the blood-based secondary biomarker panel, is associated with the future development of worrisome features and/or high-risk stigmata.
II. Estimate area under curve (AUC), sensitivity, specificity, negative, and positive predictive value of each biomarker.
III. Evaluate the predictive ability of the longitudinal trajectory of each biomarker for prediction of worrisome features and/or high-risk stigmata.
IV. Develop and evaluate risk scores that combine blood-based and imaging-based markers.
- Compare patient reported outcomes (PROs) between study arms (A and B): quality of life (QOL), financial distress, and situational anxiety.
VI. Compare 5-year total cost between arms (A and B).
PRIMARY OBJECTIVE (PRIOR TO ADDENDUM #5 08/13/2024):
- To compare the rates of unfavorable clinical outcomes in the two arms.
SECONDARY OBJECTIVES (PRIOR TO ADDENDUM #5 08/13/2024):
- 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.
- Compare patient (out-of-pocket and other indirect) costs. VI. Describe diagnostic test and treatment pathways by arm. VII. Compare patient reports of 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 (PRIOR TO ADDENDUM #5 08/13/2024):
- To evaluate and compare the predictive accuracy of known and future radiomic markers for dysplasia and pancreatic cancer.
OUTLINE: This is an observational study.
Patients undergo magnetic resonance imaging (MRI) or CT scans as well as blood sample collection throughout the trial. Patients undergo endoscopic ultrasound (EUS), fine needle aspiration (FNA), biopsy and surgery as clinically indicated.
Patients are followed up every 6 months or yearly for 5 years from the date of registration.
OUTLINE (PRIOR TO ADDENDUM #5 08/13/2024): This is an observational study. Patients are randomized to 1 of 2 arms.
ARM A (LOW INTENSITY SURVEILLANCE) (CLOSED TO ACCRUAL 08/13/2024): Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT 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.
ARM B (HIGH INTENSITY SURVEILLANCE) (CLOSED TO ACCRUAL 08/13/2024): Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 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 and < 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 alternate MRI or CT with EUS every 3-6 months.
All patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study.
After completion of imaging procedures, patients are followed up for 5 years from the date of registration.
- Conditions
- Pancreatic Neoplasm
- Being tested
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Endoscopic Ultrasound, Endoscopic Ultrasound-Guided Fine-Needle Aspiration
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Endoscopic UltrasoundProcedure or surgery
Also called endosonography, EUS
Undergo EUS
Endoscopic Ultrasound-Guided Fine-Needle AspirationProcedure or surgery
Also called endoscopic ultrasound-guided fine needle aspiration, EUS-FNA
Undergo EUS-FNA
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)
Questionnaire AdministrationOther
Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A (low intensity surveillance) | Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT 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. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024) Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Endoscopic Ultrasound; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration | |
| Arm B (high intensity surveillance) | Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 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 and < 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 alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024) Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Endoscopic Ultrasound; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration | |
| Observational | Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Endoscopic Ultrasound; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration; Procedure: Magnetic Resonance Imaging; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)
Will assess the predictive performance of both primary markers separately. Time to first occurrence of worrisome features and/or high-risk stigmata will be measured from the time of baseline blood draw. Will use an overall significance level of 0.1. Will use a Bonferroni correction for multiplicity adjustment, the significance level applied to both primary biomarkers will be 0.05. Will evaluate using a two-sided log-rank test comparing time to occurrence of worrisome features and/or high-risk stigmata between the marker-positive and marker-negative subgroups. Will visually summarize time to occurrence of worrisome features and/or high-risk stigmata in both maker positive and marker negative using Kaplan-Meier curves. All biomarkers will come in with a predetermined threshold for determining marker positivity (as defined in their respective publications). The primary imaging marker is for MRI, the analysis of this biomarker will be restricted to participants with a pre-enrollment MRI.
Measured: Up to 5 years
Occurrence of an "unfavorable" outcome (PRIOR TO ADDENDUM #5 08/13/2024)
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 be 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.
Measured: Up to 5 years
Secondary outcomes (17)
Finding of a worrisome feature and/or high-risk stigmata on CT or MRI
Will evaluate with the analog analysis plan.
Measured: Up to 5 years
Situational anxiety
Will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4-item short form. The analysis group will be the patients recruited prior to the activation of addendum #5 and randomized to either high or low intensity surveillance. A hierarchical strategy will be used. Will compare situational anxiety between arms with a two-sample unequal-variance t-test.
Measured: Up to 5 years
Overall quality of life
Will be measured using the PROMIS-10. The analysis group will be the patients recruited prior to the activation of addendum #5 and randomized to either high or low intensity surveillance. A hierarchical strategy will be used. Will compare quality of life between arms with a two-sample unequal-variance t-test.
Measured: Up to 5 years
Financial distress
Will be measured using the Comprehensive Score for Financial Toxicity measure. The analysis group will be the patients recruited prior to the activation of addendum #5 and randomized to either high or low intensity surveillance. Will compare financial distress between arms with a two-sample unequal-variance t-test.
Measured: Up to 5 years
Cost
Will evaluate the sum of Medicare reimbursement for all the healthcare utilization. Will compare total cost between arms. The analysis group will be the patients recruited prior to the activation of addendum #5 and randomized to either high or low intensity surveillance. The distribution of the cost will be examined. If it is approximately normal, then the cost between the arms will be compared using a t-test. Also, the variance in the cost will be compared to assess if it differs between the arms. If distribution is particularly skewed a transformation will be sought, and the comparison will be analyzed on that scale.
Measured: Up to 5 years
Surgical and all-cause mortality (PRIOR TO ADDENDUM #5 08/13/2024)
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.
Measured: Up to 5 years
Major surgical morbidity (PRIOR TO ADDENDUM #5 08/13/2024)
Rates of major surgical morbidity and/or mortality will be estimated and compared across arms.
Measured: Up to 5 years
Pancreatic cancer incidence (PRIOR TO ADDENDUM #5 08/13/2024)
Pancreatic-cancer incidence and pancreatic cancer specific mortality will be estimated and compared between the arms using log rank tests.
Measured: Up to 5 years
Institutional (direct) costs (PRIOR TO ADDENDUM #5 08/13/2024)
Will compare between two arms.
Measured: Up to 5 years
Healthcare utilization of imaging, invasive testing, surgical, and other procedures (PRIOR TO ADDENDUM #5 08/13/2024)
Will compare between two arms.
Measured: Up to 5 years
Patient (out-of-pocket and other indirect) costs (PRIOR TO ADDENDUM #5 08/13/2024)
Will compare between two arms.
Measured: Up to 5 years
Diagnostic test and treatment pathways (PRIOR TO ADDENDUM #5 08/13/2024)
Will describe diagnostic test and treatment pathways by arm.
Measured: Up to 5 years
Patient reports of quality of life (PRIOR TO ADDENDUM #5 08/13/2024)
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.
Measured: Up to 5 years
Patient reports of situational anxiety (PRIOR TO ADDENDUM #5 08/13/2024)
Will be assessed by Patient Reported Outcomes Measurement Information System-Anxiety short form. Will compare between arms.
Measured: Up to 5 years
Patient report of financial distress (PRIOR TO ADDENDUM #5 08/13/2024)
Will compare between arms.
Measured: Up to 5 years
Rates of non-adherence (PRIOR TO ADDENDUM #5 08/13/2024)
Will compare rates of non-adherence by arm assignment.
Measured: Up to 5 years
Biomarker analysis (PRIOR TO ADDENDUM #5 08/13/2024)
Will evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start16 Jun 2020
- Primary completion11 Nov 2034 (estimated)
- Study completion11 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David S Weinberg, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239573
- Sponsor's protocol ID
- EA2185
- Other IDs
- UG1CA189828, NCI-2019-04790, EA2185, ECOG-ACRIN-EA2185, EA2185
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32920242
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
- ClinicalTrials.gov ID
- NCT04239573
- Acronym / sponsor ID
- EA2185
- Conditions
- Pancreatic Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 11 Nov 2034 (estimated)
- Study completion
- 11 Nov 2034 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate whether the protocol specified primary biomarkers (both blood and imaging-based) measured at baseline, are associated with the future development of worrisome features and/or high-risk stigmata.
SECONDARY OBJECTIVES:
- Evaluate whether the imaging-based secondary biomarker implemented using baseline computed tomography (CT) scans and/or the blood-based secondary biomarker panel, is associated with the future development of worrisome features and/or high-risk stigmata.
II. Estimate area under curve (AUC), sensitivity, specificity, negative, and positive predictive value of each biomarker.
III. Evaluate the predictive ability of the longitudinal trajectory of each biomarker for prediction of worrisome features and/or high-risk stigmata.
IV. Develop and evaluate risk scores that combine blood-based and imaging-based markers.
- Compare patient reported outcomes (PROs) between study arms (A and B): quality of life (QOL), financial distress, and situational anxiety.
VI. Compare 5-year total cost between arms (A and B).
PRIMARY OBJECTIVE (PRIOR TO ADDENDUM #5 08/13/2024):
- To compare the rates of unfavorable clinical outcomes in the two arms.
SECONDARY OBJECTIVES (PRIOR TO ADDENDUM #5 08/13/2024):
- 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.
- Compare patient (out-of-pocket and other indirect) costs. VI. Describe diagnostic test and treatment pathways by arm. VII. Compare patient reports of 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 (PRIOR TO ADDENDUM #5 08/13/2024):
- To evaluate and compare the predictive accuracy of known and future radiomic markers for dysplasia and pancreatic cancer.
OUTLINE: This is an observational study.
Patients undergo magnetic resonance imaging (MRI) or CT scans as well as blood sample collection throughout the trial. Patients undergo endoscopic ultrasound (EUS), fine needle aspiration (FNA), biopsy and surgery as clinically indicated.
Patients are followed up every 6 months or yearly for 5 years from the date of registration.
OUTLINE (PRIOR TO ADDENDUM #5 08/13/2024): This is an observational study. Patients are randomized to 1 of 2 arms.
ARM A (LOW INTENSITY SURVEILLANCE) (CLOSED TO ACCRUAL 08/13/2024): Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT 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.
ARM B (HIGH INTENSITY SURVEILLANCE) (CLOSED TO ACCRUAL 08/13/2024): Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 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 and < 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 alternate MRI or CT with EUS every 3-6 months.
All patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study.
After completion of imaging procedures, patients are followed up for 5 years from the date of registration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (low intensity surveillance) | – | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Endoscopic Ultrasound, Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT 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. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024) |
| Arm B (high intensity surveillance) | – | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Endoscopic Ultrasound, Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo MRI, CT, or EUS at the beginning of the trial. Patients with >= 1 and < 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 and < 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 alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024) |
| Observational | – | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Endoscopic Ultrasound, Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration, Procedure: Magnetic Resonance Imaging, Procedure: Surgical ProcedurePatients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic cysts.
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Arm A (low intensity surveillance), Arm B (high intensity surveillance), Observational |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm A (low intensity surveillance), Arm B (high intensity surveillance), Observational |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm A (low intensity surveillance), Arm B (high intensity surveillance), Observational |
| Endoscopic UltrasoundAlso: endosonography, EUSUndergo EUS | Procedure or surgery | Arm A (low intensity surveillance), Arm B (high intensity surveillance), Observational |
| Endoscopic Ultrasound-Guided Fine-Needle AspirationAlso: endoscopic ultrasound-guided fine needle aspiration, EUS-FNAUndergo EUS-FNA | Procedure or surgery | Arm A (low intensity surveillance), Arm B (high intensity surveillance), Observational |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Arm A (low intensity surveillance), Arm B (high intensity surveillance), Observational |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies (PRIOR TO ADDENDUM #5 08/13/2024) | Other | Arm A (low intensity surveillance), Arm B (high intensity surveillance) |
| Questionnaire AdministrationAncillary studies (PRIOR TO ADDENDUM #5 08/13/2024) | Other | Arm A (low intensity surveillance), Arm B (high intensity surveillance) |
| Surgical ProcedureAlso: Operation, Surgery, Surgery Type, Surgery, NOSUndergo surgery | Procedure or surgery | Observational |
Primary outcome
Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)
Time frame: Up to 5 years
Will assess the predictive performance of both primary markers separately. Time to first occurrence of worrisome features and/or high-risk stigmata will be measured from the time of baseline blood draw. Will use an overall significance level of 0.1. Will use a Bonferroni correction for multiplicity adjustment, the significance level applied to both primary biomarkers will be 0.05. Will evaluate using a two-sided log-rank test comparing time to occurrence of worrisome features and/or high-risk stigmata between the marker-positive and marker-negative subgroups. Will visually summarize time to occurrence of worrisome features and/or high-risk stigmata in both maker positive and marker negative using Kaplan-Meier curves. All biomarkers will come in with a predetermined threshold for determining marker positivity (as defined in their respective publications). The primary imaging marker is for MRI, the analysis of this biomarker will be restricted to participants with a pre-enrollment MRI.
Occurrence of an "unfavorable" outcome (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
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 be 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.
17 secondary outcomes
Finding of a worrisome feature and/or high-risk stigmata on CT or MRI
Time frame: Up to 5 years
Situational anxiety
Time frame: Up to 5 years
Overall quality of life
Time frame: Up to 5 years
Financial distress
Time frame: Up to 5 years
Cost
Time frame: Up to 5 years
Surgical and all-cause mortality (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Major surgical morbidity (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Pancreatic cancer incidence (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Institutional (direct) costs (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Healthcare utilization of imaging, invasive testing, surgical, and other procedures (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Patient (out-of-pocket and other indirect) costs (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Diagnostic test and treatment pathways (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Patient reports of quality of life (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Patient reports of situational anxiety (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Patient report of financial distress (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Rates of non-adherence (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Biomarker analysis (PRIOR TO ADDENDUM #5 08/13/2024)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 32920242Weinberg 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of South Alabama Mitchell Cancer Institute
Mobile, United States
Anchorage Associates in Radiation Medicine
Anchorage, United States
David S Weinberg principal investigator
ECOG-ACRIN Cancer Research Group
429 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasm, run by ECOG-ACRIN Cancer Research Group at 429 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 429 sites in United States, Puerto Rico, Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.