Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects
Purpose
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.
Condition
- Malignancy
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational (biospecimen collection, medical record review) | 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. |
|
Recruiting Locations
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Kingman, Arizona 86401
Phoenix, Arizona 85054
Site Public Contact
855-776-0015
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Little Rock, Arkansas 72205
Arroyo Grande, California 93420
Burbank, California 91505
Fremont, California 94538
Site Public Contact
510-745-6433
Loma Linda, California 92357
Site Public Contact
800-741-8387
San Francisco, California 94110
St. Helena, California 94574
Site Public Contact
707-967-3698
Grand Junction, Colorado 81505
West Haven, Connecticut 06516
Site Public Contact
203-937-3421
Lewes, Delaware 19958
Millville, Delaware 19967
Newark, Delaware 19713
Newark, Delaware 19713
Newark, Delaware 19718
Rehoboth Beach, Delaware 19971
Wilmington, Delaware 19801
Fort Lauderdale, Florida 33308
Jacksonville, Florida 32224-9980
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855-776-0015
Boise, Idaho 83706
Boise, Idaho 83712
Caldwell, Idaho 83605
Coeur d'Alene, Idaho 83814
Fruitland, Idaho 83619
Meridian, Idaho 83642
Meridian, Idaho 83642
Nampa, Idaho 83687
Nampa, Idaho 83687
Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Alton, Illinois 62002
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618-463-5623
Aurora, Illinois 60504
Aurora, Illinois 60506
Barrington, Illinois 60010
Site Public Contact
847-842-4847
Canton, Illinois 61520
Carbondale, Illinois 62902
Carterville, Illinois 62918
Carthage, Illinois 62321
Centralia, Illinois 62801
Chicago, Illinois 60625
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773-878-8200
Chicago, Illinois 60657
Site Public Contact
773-296-5360
Crystal Lake, Illinois 60014
Danville, Illinois 61832
Decatur, Illinois 62526
Decatur, Illinois 62526
Dixon, Illinois 61021
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815-285-7800
Downers Grove, Illinois 60515
Effingham, Illinois 62401
Effingham, Illinois 62401
Elgin, Illinois 60123
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847-429-2907
Eureka, Illinois 61530
Evanston, Illinois 60201
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847-570-2109
Galesburg, Illinois 61401
Glenview, Illinois 60026
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847-570-2109
Hazel Crest, Illinois 60429
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708-799-9995
Highland Park, Illinois 60035
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847-570-2109
Kewanee, Illinois 61443
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Macomb, Illinois 61455
Mattoon, Illinois 61938
Maywood, Illinois 60153
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708-226-4357
Mount Vernon, Illinois 62864
Normal, Illinois 61761
Normal, Illinois 61761
O'Fallon, Illinois 62269
Oak Lawn, Illinois 60453-2699
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800-323-8622
Ottawa, Illinois 61350
Park Ridge, Illinois 60068
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847-384-3621
Peoria, Illinois 61615
Peoria, Illinois 61636
Peru, Illinois 61354
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815-664-4141
Princeton, Illinois 61356
Rockford, Illinois 61108
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815-227-2633
Skokie, Illinois 60076
Springfield, Illinois 62702
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217-545-7929
Springfield, Illinois 62702
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800-444-7541
Springfield, Illinois 62781
Urbana, Illinois 61801
Urbana, Illinois 61801
Washington, Illinois 61571
Yorkville, Illinois 60560
South Bend, Indiana 46601
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800-284-7370
Garden City, Kansas 67846
Great Bend, Kansas 67530
Pittsburg, Kansas 66762
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888-446-3729
Baton Rouge, Louisiana 70805
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70817
Marrero, Louisiana 70072
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Brewer, Maine 04412
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800-987-3005
Elkton, Maryland 21921
Towson, Maryland 21204
Boston, Massachusetts 02115
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617-724-5200
Boston, Massachusetts 02215
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617-667-9925
Boston, Massachusetts 02215
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877-442-3324
Alma, Michigan 48801
Alpena, Michigan 49707
Ann Arbor, Michigan 48106
Brighton, Michigan 48114
Brighton, Michigan 48114
Canton, Michigan 48188
Canton, Michigan 48188
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Detroit, Michigan 48236
East China Township, Michigan 48054
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Gladwin, Michigan 48624
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Lansing, Michigan 48912
Livonia, Michigan 48154
Macomb, Michigan 48044
Macomb, Michigan 48044
Midland, Michigan 48670
Mount Pleasant, Michigan 48858
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saginaw, Michigan 48601
Tawas City, Michigan 48764
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Bemidji, Minnesota 56601
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Edina, Minnesota 55435
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55417
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612-467-2800
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Rochester, Minnesota 55905
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855-776-0015
Saint Cloud, Minnesota 56303
Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
Site Public Contact
605-312-3320
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Worthington, Minnesota 56187
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605-312-3320
Wyoming, Minnesota 55092
Ballwin, Missouri 63011
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888-446-3729
Bolivar, Missouri 65613
Branson, Missouri 65616
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417-269-4520
Cape Girardeau, Missouri 63703
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888-446-3729
Cape Girardeau, Missouri 63703
City of Saint Peters, Missouri 63376
Creve Coeur, Missouri 63141
Farmington, Missouri 63640
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314-996-5569
Joplin, Missouri 64804
Joplin, Missouri 64804
Osage Beach, Missouri 65065
Rolla, Missouri 65401
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573-458-6379
Rolla, Missouri 65401
Saint Joseph, Missouri 64506
Sainte Genevieve, Missouri 63670
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314-996-5569
Springfield, Missouri 65804
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417-269-4520
Springfield, Missouri 65807
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417-269-4520
St Louis, Missouri 63109
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888-446-3729
St Louis, Missouri 63110
St Louis, Missouri 63128
St Louis, Missouri 63129
St Louis, Missouri 63131
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314-996-5569
St Louis, Missouri 63136
St Louis, Missouri 63141
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314-251-7066
Sullivan, Missouri 63080
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314-996-5569
Sunset Hills, Missouri 63127
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314-996-5569
Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Bozeman, Montana 59715
Great Falls, Montana 59405
Great Falls, Montana 59405
Havre, Montana 59501
Helena, Montana 59601
Kalispell, Montana 59901
Missoula, Montana 59802
Missoula, Montana 59804
Bellevue, Nebraska 68123
Omaha, Nebraska 68118
Site Public Contact
402-559-5600
Omaha, Nebraska 68198
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Las Vegas, Nevada 89103
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Las Vegas, Nevada 89109
Las Vegas, Nevada 89113
Las Vegas, Nevada 89113
Las Vegas, Nevada 89119
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89135
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89183
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Auburn, New York 13021
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315-472-7504
Buffalo, New York 14263
Camillus, New York 13031
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315-472-7504
East Syracuse, New York 13057
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315-472-7504
Oswego, New York 13126
Syracuse, New York 13210
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315-464-5476
Syracuse, New York 13215
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315-464-5476
Verona, New York 13478
Cary, North Carolina 27518
Durham, North Carolina 27710
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888-275-3853
Greenville, North Carolina 27834
Hendersonville, North Carolina 28791
Kinston, North Carolina 28501
Raleigh, North Carolina 27607
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919-785-4878
Raleigh, North Carolina 27609
Washington, North Carolina 27889
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58103
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605-312-3320
Fargo, North Dakota 58104
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800-437-4010
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Belpre, Ohio 45714
Centerville, Ohio 45459
Chillicothe, Ohio 45601
Cincinnati, Ohio 45229
Columbus, Ohio 43210
Columbus, Ohio 43213
Columbus, Ohio 43219
Columbus, Ohio 43222
Dayton, Ohio 45409
Dayton, Ohio 45409
Site Public Contact
937-276-8320
Dayton, Ohio 45415
Franklin, Ohio 45005-1066
Gahanna, Ohio 43230
Greenville, Ohio 45331
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937-569-7515
Grove City, Ohio 43123
Lancaster, Ohio 43130
Lima, Ohio 45801
Marietta, Ohio 45750
Marysville, Ohio 43040
Mount Vernon, Ohio 43050
Newark, Ohio 43055
Newark, Ohio 43055
Perrysburg, Ohio 43551
Portsmouth, Ohio 45662
Toledo, Ohio 43608
Toledo, Ohio 43623
Troy, Ohio 45373
Westerville, Ohio 43081
Wilmington, Ohio 45177
Zanesville, Ohio 43701
Oklahoma City, Oklahoma 73120
Site Public Contact
405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Hood River, Oregon 97031
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97239
Site Public Contact
800-949-1004
Redmond, Oregon 97756
Site Public Contact
541-706-2909
Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18017
Chadds Ford, Pennsylvania 19317
Chambersburg, Pennsylvania 17201
Chambersburg, Pennsylvania 17201
Site Public Contact
717-217-6020
Danville, Pennsylvania 17822
East Stroudsburg, Pennsylvania 18301
Ephrata, Pennsylvania 17522
Site Public Contact
717-721-4840
Ephrata, Pennsylvania 17522
Gettysburg, Pennsylvania 17325
Site Public Contact
877-441-7957
Hanover, Pennsylvania 17331
Site Public Contact
717-632-1559
Hazleton, Pennsylvania 18201
Hazleton, Pennsylvania 18201
Lebanon, Pennsylvania 17042
Lewistown, Pennsylvania 17044
Meadowbrook, Pennsylvania 19046
Site Public Contact
215-938-3555
Philadelphia, Pennsylvania 19104
Pottsville, Pennsylvania 17901
Wilkes-Barre, Pennsylvania 18711
York, Pennsylvania 17403
Site Public Contact
877-441-7957
York, Pennsylvania 17403
Site Public Contact
877-441-7957
Providence, Rhode Island 02908
Greenville, South Carolina 29601
Greenville, South Carolina 29607
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57117-5134
Amarillo, Texas 79106
San Antonio, Texas 78229
Site Public Contact
877-469-5300
Richmond, Virginia 23298
Aberdeen, Washington 98520
Bellingham, Washington 98225
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Renton, Washington 98055
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Spokane, Washington 99202
Spokane, Washington 99216
Spokane, Washington 99218
Vancouver, Washington 98664
Walla Walla, Washington 99362
Yakima, Washington 98902
Bridgeport, West Virginia 26330
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Princeton, West Virginia 24740
Site Public Contact
304-487-7515
Wheeling, West Virginia 26003
Site Public Contact
304-243-6442
Appleton, Wisconsin 54915
Brookfield, Wisconsin 53045
Burlington, Wisconsin 53105
Chilton, Wisconsin 53014
Cudahy, Wisconsin 53110
Franklin, Wisconsin 53132
Franklin, Wisconsin 53132
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54311
Kenosha, Wisconsin 53142
La Crosse, Wisconsin 54601
Marinette, Wisconsin 54143
Mequon, Wisconsin 53097
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53210
Milwaukee, Wisconsin 53211
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
Site Public Contact
414-805-3666
Milwaukee, Wisconsin 53233
New Richmond, Wisconsin 54017
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53405
Racine, Wisconsin 53406
Sheboygan, Wisconsin 53081
Summit, Wisconsin 53066
Two Rivers, Wisconsin 54241
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
More Details
- Status
- Recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
Detailed Description
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.