Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.
PRIMARY OBJECTIVES:
To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth).
OUTLINE:
Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.
Inclusion Criteria:
Received a regimen containing one or more immuno-oncology therapeutics
Must have experienced one or more of the following:
One or more serious (Grade 3-4) AEs that are likely immune-related
One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related
Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
** Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
Has not previously been registered to this study
dkozono@bwh.harvard.edu617-632-5734
Anchorage, Alaska 98508, United States
AKPAMC.OncologyResearchSupport@providence.org907-212-6871
Arroyo Grande, California 93420, United States
Burbank, California 91505, United States
Martinez, California 94553-3156, United States
San Luis Obispo, California 93401, United States
Santa Maria, California 93444, United States
Centennial, Colorado 80112, United States
Colorado Springs, Colorado 80907, United States
Colorado Springs, Colorado 80907, United States
Denver, Colorado 80218, United States
Englewood, Colorado 80113, United States
Englewood, Colorado 80113, United States
Englewood, Colorado 80113, United States
Lakewood, Colorado 80228, United States
Littleton, Colorado 80120, United States
Lone Tree, Colorado 80124, United States
West Haven, Connecticut 06516, United States
Wilmington, Delaware 19801, United States
Savannah, Georgia 31405, United States
Evanston, Illinois 60201, United States
Glenview, Illinois 60026, United States
Highland Park, Illinois 60035, United States
Melrose Park, Illinois 60160, United States
Clive, Iowa 50325, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Fort Dodge, Iowa 50501, United States
Bardstown, Kentucky 40004, United States
Lexington, Kentucky 40504, United States
Lexington, Kentucky 40504, United States
Lexington, Kentucky 40509, United States
London, Kentucky 40741, United States
Mount Sterling, Kentucky 40353, United States
New Orleans, Louisiana 70112, United States
Baltimore, Maryland 21201, 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 Township, Michigan 48054, United States
kforman1@hfhs.org313-343-3166
Grosse Pointe Woods, Michigan 48236, United States
Grosse Pointe Woods, Michigan 48236, United States
Marlette, Michigan 48453, United States
Southfield, Michigan 48075, United States
West Branch, Michigan 48661, United States
Ypsilanti, Michigan 48197, United States
Maple Grove, Minnesota 55369, United States
City of Saint Peters, Missouri 63376, United States
Grand Island, Nebraska 68803, United States
Omaha, Nebraska 68124, United States
Henderson, Nevada 89052, United States
Henderson, Nevada 89074, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
Las Vegas, Nevada 89128, United States
Las Vegas, Nevada 89135, United States
Las Vegas, Nevada 89144, United States
Las Vegas, Nevada 89149, United States
Las Vegas, Nevada 89169, United States
Albuquerque, New Mexico 87106, United States
Auburn, New York 13021, United States
East Syracuse, New York 13057, United States
New York, New York 10032, United States
Syracuse, New York 13210, United States
Washington, North Carolina 27889, United States
Centerville, Ohio 45459, United States
Cincinnati, Ohio 45219, United States
Franklin, Ohio 45005-1066, United States
West Chester, Ohio 45069, United States
Wilmington, Ohio 45177, United States
Chadds Ford, Pennsylvania 19317, United States
Hazleton, Pennsylvania 18201, United States
Philadelphia, Pennsylvania 19104, United States
Wilkes-Barre, Pennsylvania 18711, United States
Providence, Rhode Island 02908, United States
Bluffton, South Carolina 29910, United States
Hilton Head Island, South Carolina 29926-3827, United States
Sioux Falls, South Dakota 57117-5134, United States
Poulsbo, Washington 98370, United States
Seattle, Washington 98195, United States
Silverdale, Washington 98383, United States
Tacoma, Washington 98405, United States
Yakima, Washington 98902, United States
Appleton, Wisconsin 54915, United States
Brookfield, Wisconsin 53045, United States
Franklin, Wisconsin 53132, United States
Mequon, Wisconsin 53097, United States
Milwaukee, Wisconsin 53210, United States
Milwaukee, Wisconsin 53211, United States
Oshkosh, Wisconsin 54904, United States
Rhinelander, Wisconsin 54501, United States
Stevens Point, Wisconsin 54482, United States
Summit, Wisconsin 53066, United States
ncorp@aurora.org414-302-2304
Wauwatosa, Wisconsin 53226, United States
Wisconsin Rapids, Wisconsin 54494, United States
AKPAMC.OncologyResearchSupport@providence.org907-212-6871
AKPAMC.OncologyResearchSupport@providence.org907-212-6871
AKPAMC.OncologyResearchSupport@providence.org907-212-6871
AKPAMC.OncologyResearchSupport@providence.org907-212-6871
AKPAMC.OncologyResearchSupport@providence.org907-212-6871
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855-776-0015
800-378-9373
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510-248-1600
800-741-8387
Paul.Couey@ucsf.edu415-476-4082
707-967-3698
gvoclinicaltrials@gjhosp.org970-644-4460
203-937-3421 ext. 2832
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lbarone@christianacare.org302-623-4450
eileen.georgi@holy-cross.com
855-776-0015
stephanie.couch@stjoeshealth.org734-712-3671
eslinget@slhs.org208-381-2774
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mccinfo@mtcancer.org406-969-6060
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eslinget@slhs.org208-381-2774
mccinfo@mtcancer.org406-969-6060
mccinfo@mtcancer.org406-969-6060
eslinget@slhs.org208-381-2774
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ncorp@aah.org
847-842-4847
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773-296-5360
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Research@carle.com800-446-5532
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800-323-8622
andersonj@illinoiscancercare.com309-243-3605
847-384-3621
andersonj@illinoiscancercare.com309-243-3605
andersonj@illinoiscancercare.com309-243-3605
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Research@carle.com800-446-5532
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Cancer.Research@rushcopley.com630-978-6212
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aroland@kccop.org913-948-5588
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617-667-9925
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MCRCwebsitecontactform@stjoeshealth.org734-712-7251
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Kkeenan1@hfhs.org313-343-3166
wstrong@ghci.org810-762-8038
wstrong@ghci.org810-762-8038
wstrong@ghci.org810-762-8038
wstrong@ghci.org810-762-8038
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kforman1@hfhs.org313-343-3166
karen.forman@ascension.org313-343-3166
kforman1@hfhs.org313-343-3166
harsha.trivedi@umhsparrow.org517-364-3712
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
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CVResearch@mymichigan.org989-631-2469
Emily.Crofts@trinity-health.org248-858-6215
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
OncologyClinicalTrialsFargo@sanfordhealth.org218-333-5000
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
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mmcorc@healthpartners.com952-993-1517
855-776-0015
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mmcorc@healthpartners.com952-993-1517
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605-312-3320
mmcorc@healthpartners.com952-993-1517
888-446-3729
aroland@kccop.org913-948-5588
417-269-4520
888-446-3729
sfmc@sfmc.net573-334-2230
info@siteman.wustl.edu800-600-3606
info@siteman.wustl.edu800-600-3606
314-996-5569
LJCrockett@freemanhealth.com417-347-4030
esmeralda.carrillo@mercy.net417-556-3074
clinicaltrials@lakeregional.com573-302-2768
573-458-6379
research@phelpshealth.org573-458-7504
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314-996-5569
417-269-4520
417-269-4520
888-446-3729
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314-996-5569
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314-251-7066
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636-390-1600
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mccinfo@mtcancer.org406-969-6060
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mccinfo@mtcancer.org406-969-6060
protocols@AllianceNCTN.org773-702-9171
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Renown-CRD@renown.org775-982-5050
research@sncrf.org702-384-0013
201-894-3456
315-472-7504
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315-472-7504
315-472-7504
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315-464-5476
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701-234-6161
605-312-3320
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Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
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937-276-8320
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
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Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
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Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
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