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Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects

RecruitingObservational study

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

Who can join

All ages · All sexes

Full eligibility criteria
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Planning to receive a regimen containing one or more IO therapeutics
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Has not previously been treated with CTLA-4, PD-1 or PD-L1 inhibitors
* PRE-REGISTRATION ELIGIBILITY CRITERIA: Willing and able to provide baseline blood and stool samples
* REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics

  * Must have received one or more IO therapeutics
  * In addition to one or more IO therapeutics, patients may also have received other therapeutics such as chemotherapy, hormonal or targeted therapy, as long as these are reported
* REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following:

  * One or more serious (grade 3-54) AEs that are likely immune-related. AEs included in Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 that may be immune-related

    \*\* Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded
  * One or more grade 2 dermatologic, endocrine (except diabetes/hyperglycemia) or rheumatologic AEs that are likely immune-related. AEs included in CTCAE v. 5.0 that may be 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
* REGISTRATION ELIGIBILITY CRITERIA: Has not previously been registered to this study \* The same patient cannot be enrolled more than once to this study due to development of subsequent irAEs

About the study

This study 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.

What is being tested

Sponsor: Alliance for Clinical Trials in Oncology · Participants: 2,240 · Started: Mar 12, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04242095

Locations in the U.S.

AlaskaAlaska Breast Care and Surgery LLC, Anchorage
Alaska Oncology and Hematology LLC, Anchorage
Alaska Women's Cancer Care, Anchorage
Anchorage Associates in Radiation Medicine, Anchorage
Katmai Oncology Group, Anchorage
Providence Alaska Medical Center, Anchorage
ArizonaKingman Regional Medical Center, Kingman
Mayo Clinic Hospital in Arizona, Phoenix
ArkansasMercy Hospital Fort Smith, Fort Smith
CARTI Cancer Center, Little Rock
CaliforniaPCR Oncology, Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank
Washington Health, Fremont
Veterans Affairs Loma Linda Healthcare System, Loma Linda
Zuckerberg San Francisco General Hospital, San Francisco
Saint Helena Hospital, St. Helena
ColoradoGrand Valley Oncology, Grand Junction
ConnecticutVeterans Affairs Connecticut Healthcare System-West Haven Campus, West Haven
DelawareBeebe Medical Center, Lewes
Beebe South Coastal Health Campus, Millville
Christiana Care Health System-Christiana Hospital, Newark
Helen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
Beebe Health Campus, Rehoboth Beach
Christiana Care Health System-Wilmington Hospital, Wilmington
FloridaHoly Cross Hospital, Fort Lauderdale
Mayo Clinic in Florida, Jacksonville
IdahoSaint Alphonsus Cancer Care Center-Boise, Boise
Saint Luke's Cancer Institute - Boise, Boise
Saint Alphonsus Cancer Care Center-Caldwell, Caldwell
Kootenai Health - Coeur d'Alene, Coeur d'Alene
Saint Luke's Cancer Institute - Fruitland, Fruitland
Idaho Urologic Institute-Meridian, Meridian
Saint Luke's Cancer Institute - Meridian, Meridian
Saint Alphonsus Cancer Care Center-Nampa, Nampa
Saint Luke's Cancer Institute - Nampa, Nampa
Kootenai Clinic Cancer Services - Post Falls, Post Falls
Kootenai Clinic Cancer Services - Sandpoint, Sandpoint
Saint Luke's Cancer Institute - Twin Falls, Twin Falls
IllinoisOSF Saint Anthony's Health Center, Alton
Advocate Outpatient Center - Aurora, Aurora
Rush-Copley Medical Center, Aurora
Advocate Good Shepherd Hospital, Barrington
Illinois CancerCare-Canton, Canton
Memorial Hospital of Carbondale, Carbondale
SIH Cancer Institute, Carterville
Illinois CancerCare-Carthage, Carthage
Centralia Oncology Clinic, Centralia
Advocate Illinois Masonic Medical Center, Chicago
Swedish Covenant Hospital, Chicago
AMG Crystal Lake - Oncology, Crystal Lake
Carle at The Riverfront, Danville
Cancer Care Specialists of Illinois - Decatur, Decatur
Decatur Memorial Hospital, Decatur
Illinois CancerCare-Dixon, Dixon
Advocate Good Samaritan Hospital, Downers Grove
Carle Physician Group-Effingham, Effingham
Crossroads Cancer Center, Effingham
Advocate Sherman Hospital, Elgin
Illinois CancerCare-Eureka, Eureka
NorthShore University HealthSystem-Evanston Hospital, Evanston
Illinois CancerCare-Galesburg, Galesburg
NorthShore University HealthSystem-Glenbrook Hospital, Glenview
Advocate South Suburban Hospital, Hazel Crest
NorthShore University HealthSystem-Highland Park Hospital, Highland Park
Illinois CancerCare-Kewanee Clinic, Kewanee
AMG Libertyville - Oncology, Libertyville
Condell Memorial Hospital, Libertyville
Illinois CancerCare-Macomb, Macomb
Carle Physician Group-Mattoon/Charleston, Mattoon
Loyola University Medical Center, Maywood
SSM Health Good Samaritan, Mount Vernon
Carle BroMenn Medical Center, Normal
Carle Cancer Institute Normal, Normal
HSHS Saint Elizabeth's Hospital, O'Fallon
Advocate Christ Medical Center, Oak Lawn
Illinois CancerCare-Ottawa Clinic, Ottawa
Advocate Lutheran General Hospital, Park Ridge
Illinois CancerCare-Peoria, Peoria
Methodist Medical Center of Illinois, Peoria
Valley Radiation Oncology, Peru
Illinois CancerCare-Princeton, Princeton
OSF Saint Anthony Medical Center, Rockford
North Shore Medical Center, Skokie
Southern Illinois University School of Medicine, Springfield
Springfield Clinic, Springfield
Springfield Memorial Hospital, Springfield
Carle Cancer Center, Urbana
The Carle Foundation Hospital, Urbana
Illinois CancerCare - Washington, Washington
Rush-Copley Healthcare Center, Yorkville
IndianaMemorial Hospital of South Bend, South Bend
KansasCentral Care Cancer Center - Garden City, Garden City
Central Care Cancer Center - Great Bend, Great Bend
Mercy Hospital Pittsburg, Pittsburg
LouisianaLSU Health Baton Rouge-North Clinic, Baton Rouge
Our Lady of the Lake Medical Oncology, Baton Rouge
Our Lady of the Lake Physician Group, Baton Rouge
West Jefferson Medical Center, Marrero
Louisiana State University Health Science Center, New Orleans
University Medical Center New Orleans, New Orleans
MaineLafayette Family Cancer Center-EMMC, Brewer
MarylandChristiana Care - Union Hospital, Elkton
UM Saint Joseph Medical Center, Towson
MassachusettsBeth Israel Deaconess Medical Center, Boston
Brigham and Women's Hospital, Boston
Dana-Farber Cancer Institute, Boston
MichiganMyMichigan Medical Center Gratiot, Alma
MyMichigan Medical Center Alpena, Alpena
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton
Trinity Health Medical Center - Brighton, Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton
Trinity Health Medical Center - Canton, Canton
Chelsea Hospital, Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea
Hematology Oncology Consultants-Clarkston, Clarkston
Henry Ford Health Saint John Hospital, Detroit
Henry Ford River District Hospital, East China
Cancer Hematology Centers - Flint, Flint
Genesee Hematology Oncology PC, Flint
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
MyMichigan Medical Center Gladwin, Gladwin
Henry Ford Saint John Hospital - Academic, Grosse Pointe Woods
Henry Ford Saint John Hospital - Breast, Grosse Pointe Woods
Henry Ford Saint John Hospital - Van Elslander, Grosse Pointe Woods
University of Michigan Health - Sparrow Lansing, Lansing
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia
Henry Ford Saint John Hospital - Macomb Medical, Macomb
Henry Ford Warren Hospital - Breast Macomb, Macomb
MyMichigan Medical Center Midland, Midland
MyMichigan Medical Center Mount Pleasant, Mount Pleasant
Michigan Healthcare Professionals Pontiac, Pontiac
Newland Medical Associates-Pontiac, Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac
MyMichigan Medical Center Saginaw, Saginaw
MyMichigan Medical Center Tawas, Tawas City
Henry Ford Health Warren Hospital, Warren
Henry Ford Madison Heights Hospital - Breast, Warren
Henry Ford Warren Hospital - GLCMS, Warren
Huron Gastroenterology PC, Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti
MinnesotaSanford Joe Lueken Cancer Center, Bemidji
Minnesota Oncology - Burnsville, Burnsville
Mercy Hospital, Coon Rapids
Fairview Southdale Hospital, Edina
Fairview Clinics and Surgery Center Maple Grove, Maple Grove
Minnesota Oncology Hematology PA-Maplewood, Maplewood
Saint John's Hospital - Healtheast, Maplewood
Abbott-Northwestern Hospital, Minneapolis
Hennepin County Medical Center, Minneapolis
Minneapolis VA Medical Center, Minneapolis
Monticello Cancer Center, Monticello
New Ulm Medical Center, New Ulm
Fairview Northland Medical Center, Princeton
North Memorial Medical Health Center, Robbinsdale
Mayo Clinic in Rochester, Rochester
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
United Hospital, Saint Paul
Saint Francis Regional Medical Center, Shakopee
Lakeview Hospital, Stillwater
Sanford Thief River Falls Medical Center, Thief River Falls
Ridgeview Medical Center, Waconia
Rice Memorial Hospital, Willmar
Minnesota Oncology Hematology PA-Woodbury, Woodbury
Sanford Cancer Center Worthington, Worthington
Fairview Lakes Medical Center, Wyoming
MissouriMercy Oncology and Hematology - Clayton-Clarkson, Ballwin
Central Care Cancer Center - Bolivar, Bolivar
Cox Cancer Center Branson, Branson
Mercy Cancer Center - Cape Girardeau, Cape Girardeau
Saint Francis Medical Center, Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters
Siteman Cancer Center at West County Hospital, Creve Coeur
Parkland Health Center - Farmington, Farmington
Freeman Health System, Joplin
Mercy Hospital Joplin, Joplin
Lake Regional Hospital, Osage Beach
Mercy Clinic-Rolla-Cancer and Hematology, Rolla
Phelps Health Delbert Day Cancer Institute, Rolla
Heartland Regional Medical Center, Saint Joseph
Sainte Genevieve County Memorial Hospital, Sainte Genevieve
CoxHealth South Hospital, Springfield
Mercy Hospital Springfield, Springfield
Mercy Hospital Saint Louis, St Louis
Mercy Hospital South, St Louis
Mercy Infusion Center - Chippewa, St Louis
Missouri Baptist Medical Center, St Louis
Siteman Cancer Center at Christian Hospital, St Louis
Siteman Cancer Center-South County, St Louis
Washington University School of Medicine, St Louis
Missouri Baptist Sullivan Hospital, Sullivan
Mercy Hospital Washington, Washington
MontanaCommunity Hospital of Anaconda, Anaconda
Billings Clinic Cancer Center, Billings
Bozeman Health Deaconess Hospital, Bozeman
Benefis Sletten Cancer Institute, Great Falls
Great Falls Clinic, Great Falls
Hi-Line Sletten Cancer Center, Havre
Benefis Helena Specialty Center, Helena
Logan Health Medical Center, Kalispell
Community Medical Center, Missoula
Saint Patrick Hospital - Community Hospital, Missoula
NebraskaNebraska Medicine-Bellevue, Bellevue
Nebraska Medicine-Village Pointe, Omaha
University of Nebraska Medical Center, Omaha
NevadaCarson Tahoe Regional Medical Center, Carson City
Comprehensive Cancer Centers of Nevada - Henderson, Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson
Oncology Las Vegas - Henderson, Henderson
Urology Specialists of Nevada - Green Valley, Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas
Comprehensive Cancer Centers of Nevada, Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas
Hope Cancer Care of Nevada, Las Vegas
Oncology Las Vegas - Tenaya, Las Vegas
OptumCare Cancer Care at Charleston, Las Vegas
OptumCare Cancer Care at Fort Apache, Las Vegas
OptumCare Cancer Care at MountainView, Las Vegas
Radiation Oncology Centers of Nevada Central, Las Vegas
Radiation Oncology Centers of Nevada Southeast, Las Vegas
Summerlin Hospital Medical Center, Las Vegas
Sunrise Hospital and Medical Center, Las Vegas
University Medical Center of Southern Nevada, Las Vegas
Urology Specialists of Nevada - Central, Las Vegas
Urology Specialists of Nevada - Northwest, Las Vegas
Urology Specialists of Nevada - Southwest, Las Vegas
Hope Cancer Care of Nevada-Pahrump, Pahrump
Renown Regional Medical Center, Reno
Saint Mary's Regional Medical Center, Reno
New JerseyEnglewood Hospital and Medical Center, Englewood
New YorkHematology Oncology Associates of Central New York-Auburn, Auburn
Roswell Park Cancer Institute, Buffalo
Hematology Oncology Associates of CNY at Camillus, Camillus
Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse
Upstate Cancer Center at Oswego, Oswego
SUNY Upstate Medical Center-Community Campus, Syracuse
State University of New York Upstate Medical University, Syracuse
Upstate Cancer Center at Verona, Verona
North CarolinaDuke Cancer Center Cary, Cary
Duke University Medical Center, Durham
East Carolina University, Greenville
Margaret R Pardee Memorial Hospital, Hendersonville
ECU Health Oncology Kinston, Kinston
Duke Cancer Center Raleigh, Raleigh
Duke Women's Cancer Care Raleigh, Raleigh
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital, Washington
North DakotaSanford Bismarck Medical Center, Bismarck
Sanford Broadway Medical Center, Fargo
Sanford Medical Center Fargo, Fargo
Sanford Roger Maris Cancer Center, Fargo
Sanford South University Medical Center, Fargo
Southpointe-Sanford Medical Center Fargo, Fargo
OhioStrecker Cancer Center-Belpre, Belpre
Miami Valley Hospital South, Centerville
Adena Regional Medical Center, Chillicothe
Cincinnati Children's Hospital Medical Center, Cincinnati
Mount Carmel East Hospital, Columbus
Mount Carmel Health Center West, Columbus
Ohio State University Comprehensive Cancer Center, Columbus
The Mark H Zangmeister Center, Columbus
Miami Valley Hospital, Dayton
Miami Valley Hospital North, Dayton
Premier Blood and Cancer Center, Dayton
Atrium Medical Center-Middletown Regional Hospital, Franklin
Central Ohio Breast and Endocrine Surgery, Gahanna
Miami Valley Cancer Care and Infusion, Greenville
Mount Carmel Grove City Hospital, Grove City
Fairfield Medical Center, Lancaster
Saint Rita's Medical Center, Lima
Marietta Memorial Hospital, Marietta
Memorial Hospital, Marysville
Knox Community Hospital, Mount Vernon
Licking Memorial Hospital, Newark
Newark Radiation Oncology, Newark
Mercy Health - Perrysburg Hospital, Perrysburg
Southern Ohio Medical Center, Portsmouth
Mercy Health - Saint Anne Hospital, Toledo
Mercy Health - Saint Vincent Hospital, Toledo
Upper Valley Medical Center, Troy
Saint Ann's Hospital, Westerville
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center, Wilmington
Genesis Healthcare System Cancer Care Center, Zanesville
OklahomaMercy Hospital Oklahoma City, Oklahoma City
OregonSaint Alphonsus Cancer Care Center-Baker City, Baker City
Saint Charles Health System, Bend
Clackamas Radiation Oncology Center, Clackamas
Bay Area Hospital, Coos Bay
Providence Hood River Memorial Hospital, Hood River
Providence Newberg Medical Center, Newberg
Saint Alphonsus Cancer Care Center-Ontario, Ontario
Providence Willamette Falls Medical Center, Oregon City
Portland VA Medical Center, Portland
Providence Portland Medical Center, Portland
Providence Saint Vincent Medical Center, Portland
Saint Charles Health System-Redmond, Redmond
PennsylvaniaLehigh Valley Hospital-Cedar Crest, Allentown
Lehigh Valley Hospital - Muhlenberg, Bethlehem
Christiana Care Health System-Concord Health Center, Chadds Ford
Chambersburg Hospital, Chambersburg
WellSpan Medical Oncology and Hematology, Chambersburg
Geisinger Medical Center, Danville
Pocono Medical Center, East Stroudsburg
Ephrata Cancer Center, Ephrata
Ephrata Community Hospital, Ephrata
Adams Cancer Center, Gettysburg
WellSpan Medical Oncology and Hematology, Hanover
Geisinger Medical Center-Cancer Center Hazleton, Hazleton
Lehigh Valley Hospital-Hazleton, Hazleton
Sechler Family Cancer Center, Lebanon
Lewistown Hospital, Lewistown
Redeemer Health, Meadowbrook
Philadelphia Veterans Administration Medical Center, Philadelphia
Geisinger Cancer Services-Pottsville, Pottsville
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
WellSpan Health-York Cancer Center, York
WellSpan Health-York Hospital, York
Rhode IslandRoger Williams Medical Center, Providence
South CarolinaSaint Francis Cancer Center, Greenville
Saint Francis Hospital, Greenville
South DakotaAvera Cancer Institute, Sioux Falls
Sanford Cancer Center Oncology Clinic, Sioux Falls
Sanford USD Medical Center - Sioux Falls, Sioux Falls
TexasThe Don and Sybil Harrington Cancer Center, Amarillo
Audie L Murphy VA Hospital, San Antonio
VirginiaVCU Massey Comprehensive Cancer Center, Richmond
WashingtonProvidence Regional Cancer System-Aberdeen, Aberdeen
PeaceHealth Saint Joseph Medical Center, Bellingham
Providence Regional Cancer System-Centralia, Centralia
Swedish Cancer Institute-Edmonds, Edmonds
Providence Regional Cancer Partnership, Everett
Swedish Cancer Institute-Issaquah, Issaquah
Kadlec Clinic Hematology and Oncology, Kennewick
Providence Regional Cancer System-Lacey, Lacey
PeaceHealth Saint John Medical Center, Longview
Skagit Regional Health Cancer Care Center, Mount Vernon
Valley Medical Center, Renton
Swedish Medical Center-Ballard Campus, Seattle
Swedish Medical Center-Cherry Hill, Seattle
Swedish Medical Center-First Hill, Seattle
PeaceHealth United General Medical Center, Sedro-Woolley
Cancer Care Northwest - Spokane South, Spokane
Cancer Care Northwest-North Spokane, Spokane
Cancer Care Northwest-Valley, Spokane
PeaceHealth Southwest Medical Center, Vancouver
Providence Saint Mary Regional Cancer Center, Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima
West VirginiaUnited Hospital Center, Bridgeport
WVUH-Berkely Medical Center, Martinsburg
West Virginia University Healthcare, Morgantown
Camden Clark Medical Center, Parkersburg
Princeton Community Hospital, Princeton
Wheeling Hospital/Schiffler Cancer Center, Wheeling
WisconsinAscension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton, Appleton
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield, Brookfield
Aurora Cancer Care-Southern Lakes VLCC, Burlington
Ascension Calumet Hospital-Chilton, Chilton
Aurora Saint Luke's South Shore, Cudahy
Ascension Southeast Wisconsin Hospital - Franklin, Franklin
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson, Franklin
Aurora Health Care Germantown Health Center, Germantown
Aurora Cancer Care-Grafton, Grafton
Aurora BayCare Medical Center, Green Bay
Aurora Cancer Care-Kenosha South, Kenosha
Gundersen Lutheran Medical Center, La Crosse
Aurora Bay Area Medical Group-Marinette, Marinette
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon, Mequon
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus, Milwaukee
Ascension Saint Francis Hospital-Milwaukee, Milwaukee
Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee, Milwaukee
Aurora Cancer Care-Milwaukee, Milwaukee
Aurora Saint Luke's Medical Center, Milwaukee
Aurora Sinai Medical Center, Milwaukee
Medical College of Wisconsin, Milwaukee
Cancer Center of Western Wisconsin, New Richmond
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh, Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh
Ascension All Saints Hospital-Spring Street-Racine, Racine
Aurora Cancer Care-Racine, Racine
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan
Aurora Medical Center in Summit, Summit
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa, Wauwatosa
Aurora Cancer Care-Milwaukee West, Wauwatosa
Aurora West Allis Medical Center, West Allis
WyomingMemorial Hospital of Laramie County, Cheyenne
Billings Clinic-Cody, Cody

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.