Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
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.
PRIMARY OBJECTIVE:
I. 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:
I. 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.
V. 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):
I. To compare the rates of unfavorable clinical outcomes in the two arms.
SECONDARY OBJECTIVES (PRIOR TO ADDENDUM #5 08/13/2024):
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 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):
I. 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.
Inclusion Criteria:
Birmingham, Alabama 35233, United States
gingerreeves@uabmc.edu
Burbank, California 91505, United States
Loma Linda, California 92357, United States
Sacramento, California 95817, United States
Glastonbury, Connecticut 06033, United States
Greenwich, Connecticut 06830, United States
Hartford, Connecticut 06105, United States
North Haven, Connecticut 06473, United States
West Haven, Connecticut 06516, United States
Wilmington, Delaware 19801, United States
Washington D.C., District of Columbia 20007, United States
Evanston, Illinois 60201, United States
Glenview, Illinois 60026, United States
Highland Park, Illinois 60035, United States
Lake Forest, Illinois 60045, United States
Indianapolis, Indiana 46202, United States
Clive, Iowa 50325, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Glen Burnie, Maryland 21061, United States
Ann Arbor, Michigan 48106, United States
Brighton, Michigan 48114, United States
Canton, Michigan 48188, United States
Chelsea, Michigan 48118, United States
East China, Michigan 48054, United States
kforman1@hfhs.org313-343-3166
Grand Rapids, Michigan 49503, United States
Grand Rapids, Michigan 49503, United States
Grosse Pointe Woods, Michigan 48236, United States
Grosse Pointe Woods, Michigan 48236, United States
Norton Shores, Michigan 49444, United States
Royal Oak, Michigan 48073, United States
Saint Joseph, Michigan 49085, United States
Saint Joseph, Michigan 49085, United States
Ypsilanti, Michigan 48197, United States
Lebanon, New Hampshire 03756, United States
East Orange, New Jersey 07018-1095, United States
Pennington, New Jersey 08534, United States
New York, New York 10016, United States
Chapel Hill, North Carolina 27599, United States
Hillsborough, North Carolina 27278, United States
Winston-Salem, North Carolina 27157, United States
Centerville, Ohio 45459, United States
Bethlehem, Pennsylvania 18015, United States
Chadds Ford, Pennsylvania 19317, United States
Philadelphia, Pennsylvania 19104, United States
Wilkes-Barre, Pennsylvania 18711, United States
Boiling Springs, South Carolina 29316, United States
Clinton, South Carolina 29325, United States
Easley, South Carolina 29640, United States
Georgetown, South Carolina 29440, United States
Greenville, South Carolina 29605, United States
Greenville, South Carolina 29605, United States
Greenville, South Carolina 29615, United States
Greer, South Carolina 29650, United States
Seneca, South Carolina 29672, United States
Sioux Falls, South Dakota 57117-5134, United States
Memphis, Tennessee 38120, United States
Houston, Texas 77030, United States
San Antonio, Texas 78229, United States
Berlin Corners, Vermont 05602, United States
Burlington, Vermont 05405, United States
Yakima, Washington 98902, United States
Morgantown, West Virginia 26506, United States
Janesville, Wisconsin 53548, United States
Madison, Wisconsin 53718, United States
Madison, Wisconsin 53792, United States
Stevens Point, Wisconsin 54482, United States
Summit, Wisconsin 53066, United States
ncorp@aurora.org414-302-2304
pfrancisco@usouthal.edu251-445-9870
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501-686-8274
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canceranswers@yale.edu203-785-5702
canceranswers@yale.edu203-785-5702
canceranswers@yale.edu203-785-5702
canceranswers@yale.edu203-785-5702
canceranswers@yale.edu203-785-5702
canceranswers@yale.edu203-785-5702
canceranswers@yale.edu203-785-5702
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863-904-1900
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404-778-1868
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stephanie.couch@stjoeshealth.org734-712-3671
eslinget@slhs.org208-381-2774
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eslinget@slhs.org208-381-2774
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847-842-4847
Research@Carle.com800-446-5532
andersonj@illinoiscancercare.com309-243-3605
andersonj@illinoiscancercare.com309-243-3605
clinical.research@sih.net618-457-5200
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andersonj@illinoiscancercare.com309-243-3605
morganthaler.jodi@mhsil.com217-876-4762
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773-296-5360
advocateresearch@advocate.com630-929-6129
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morganthaler.jodi@mhsil.com217-876-4762
Donald.Smith3@nm.org630-352-5360
815-285-7800
Barbara.barhamand@advocatehealth.com630-275-1270
Research@carle.com800-446-5532
morganthaler.jodi@mhsil.com217-876-4762
847-429-2907
Jrohde@emhc.org630-758-5460
andersonj@illinoiscancercare.com309-243-3605
andersonj@illinoiscancercare.com309-243-3605
Donald.Smith3@nm.org630-352-5360
708-799-9995
andersonj@illinoiscancercare.com309-243-3605
advocateresearch@advocatehealth.com630-929-6129
advocateresearch@advocatehealth.com630-929-6129
andersonj@illinoiscancercare.com309-243-3605
Research@carle.com800-446-5532
630-646-6075
Research@Carle.com800-446-5532
Research@Carle.com800-446-5532
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morganthaler.jodi@mhsil.com217-876-4762
nctnprogram_rhlccc@northwestern.edu
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nctnprogram_rhlccc@northwestern.edu
andersonj@illinoiscancercare.com309-243-3605
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andersonj@illinoiscancercare.com309-243-3605
andersonj@illinoiscancercare.com309-243-3605
andersonj@illinoiscancercare.com309-243-3605
andersonj@illinoiscancercare.com309-243-3605
815-664-4141
Cancerresearch@edward.org630-646-6075
andersonj@illinoiscancercare.com309-243-3605
217-545-7929
800-444-7541
pallante.beth@mhsil.com217-528-7541
Research@carle.com800-446-5532
Research@carle.com800-446-5532
Donald.Smith3@nm.org630-352-5360
andersonj@illinoiscancercare.com309-243-3605
iutrials@iu.edu317-278-5632
515-241-3305
515-241-3305
515-241-3305
515-241-3305
515-241-6727
515-241-3305
515-241-3305
515-241-3305
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515-241-3305
515-241-3305
research@ololrmc.com225-765-7659
research@ololrmc.com225-765-7659
225-765-7659
frank.crum@christianacare.org410-443-1360
CVResearch@mymichigan.org989-631-2469
CVResearch@mymichigan.org989-631-2469
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
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crcwm-regulatory@crcwm.org616-391-1230
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
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248-551-7695
Kkeenan1@hfhs.org313-343-3166
248-551-7695
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wstrong@ghci.org810-762-8038
wstrong@ghci.org810-762-8038
wstrong@ghci.org810-762-8038
CVResearch@mymichigan.org989-631-2469
crcwm-regulatory@crcwm.org616-391-1230
crcwm-regulatory@crcwm.org616-391-1230
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karen.forman@ascension.org313-343-3166
kforman1@hfhs.org313-343-3166
crcwm-regulatory@crcwm.org616-391-1230
crcwm-regulatory@crcwm.org616-391-1230
574-647-7370
574-647-7370
harsha.trivedi@umhsparrow.org517-364-3712
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
CVResearch@mymichigan.org989-631-2469
CVResearch@mymichigan.org989-631-2469
crcwm-regulatory@crcwm.org616-391-1230
616-391-1230
Emily.Crofts@trinity-health.org248-858-6215
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
crcwm-regulatory@crcwm.org616-391-1230
248-551-7695
248-551-7695
248-551-7695
248-551-7695
248-551-7695
248-551-7695
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
crcwm-regulatory@crcwm.org616-391-1230
crcwm-regulatory@crcwm.org616-391-1230
248-551-7695
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
crcwm-regulatory@crcwm.org616-391-1230
248-551-7695
248-551-7695
248-551-7695
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
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314-996-5569
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314-996-5569
amy.hanneman@providence.org406-327-3118
201-894-3456
732-303-5047
973-971-5900
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908-522-2043
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518-926-6700
516-734-8896
212-434-4460
516-734-8896
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eskwak@montefiore.org718-379-6866
eskwak@montefiore.org718-379-6866
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cancerclinicaltrials@med.unc.edu877-668-0683
VHADURcancertrials@va.gov919-286-0411
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701-234-6161
605-312-3320
800-437-4010
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