An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study (DiRECT)

Disparities in Results of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting

This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Electronic Health Record Review; Other: Interview; Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVE:

I. To compare incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs) between African American (AA) and European American (EA) patients within the first year of starting immune checkpoint inhibitor (ICI) treatment.

SECONDARY OBJECTIVES:

I. To compare objective response rate (ORR) to ICI treatment between AA and EA patients within the first year of starting ICI treatment.

II. To compare health-related quality of life (HRQOL) measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Preference (Patient Reported Outcomes [PRO] Pr) summary score and Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) between AA and EA patients within 1 year of starting ICI treatment.

EXPLORATORY OBJECTIVES:

I. To compare AA and EA patients on severity (i.e., CTCAE grade) and timing of irAEs within 1 year of starting ICI treatment.

II. To assess disease, treatment, individual, and behavioral factors as predictors of grade 2-5 irAEs, and as potential causes of racial differences in irAEs, within 1 year of starting ICI treatment.

III. To compare AA and EA patients on long-term outcomes (e.g., progression-free survival [PFS], overall survival [OS], and HRQOL beyond the first year) at the end of the study period.

IV. To assess the impact of irAEs and disease, treatment, behavioral, and individual factors on ICI outcomes (ORR, HRQOL, PFS, OS), and as potential causes of racial differences in outcomes, at the end of the study period.

V. To compare ICI treatment patterns (e.g., delay and discontinuation of ICI treatment) between AA and EA patients within 1 year of starting ICI treatment.

VI. To assess irAEs, treatment, disease, and individual factors, including healthcare barriers, as possible reasons for suboptimal treatment patterns, and as potential causes of racial differences, within 1 year of starting ICI treatment.

VII. To collect optional stool samples and an additional blood sample at the time of the occurrence of grade 3-4 irAEs to strengthen the biobank for future research on ICI response and racial disparities.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo collection of blood, saliva, and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.

• Study Type: Observational
• Enrollment (Estimated): 2100

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  • California
    • Anaheim, California, United States, 92806
      • Kaiser Permanente-Anaheim
    • Antioch, California, United States, 94531
      • Kaiser Permanente-Deer Valley Medical Center
    • Baldwin Park, California, United States, 91706
      • Kaiser Permanente-Baldwin Park
    • Bellflower, California, United States, 90706
      • Kaiser Permanente-Bellflower
    • Dublin, California, United States, 94568
      • Kaiser Permanente Dublin
    • Fontana, California, United States, 92335
      • Kaiser Permanente-Fontana
    • Fremont, California, United States, 94538
      • Kaiser Permanente-Fremont
    • Fresno, California, United States, 93720
      • Kaiser Permanente-Fresno
    • Harbor City, California, United States, 90710
      • Kaiser Permanente South Bay
    • Irvine, California, United States, 92618
      • Kaiser Permanente-Irvine
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90034
      • Kaiser Permanente West Los Angeles
    • Modesto, California, United States, 95356
      • Kaiser Permanente-Modesto
    • Oakland, California, United States, 94611
      • Kaiser Permanente-Oakland
    • Ontario, California, United States, 91761
      • Kaiser Permanente-Ontario
    • Panorama City, California, United States, 91402
      • Kaiser Permanente - Panorama City
    • Redwood City, California, United States, 94063
      • Kaiser Permanente- Marshall Medical Offices
    • Richmond, California, United States, 94801
      • Kaiser Permanente-Richmond
    • Riverside, California, United States, 92505
      • Kaiser Permanente-Riverside
    • Roseville, California, United States, 95661
      • Kaiser Permanente-Roseville
    • Sacramento, California, United States, 95814
      • Kaiser Permanente Downtown Commons
    • Sacramento, California, United States, 95823
      • Kaiser Permanente-South Sacramento
    • San Diego, California, United States, 92120
      • Kaiser Permanente-San Diego Zion
    • San Diego, California, United States, 92108
      • Kaiser Permanente-San Diego Mission
    • San Francisco, California, United States, 94115
      • Kaiser Permanente-San Francisco
    • San Jose, California, United States, 95119
      • Kaiser Permanente-Santa Teresa-San Jose
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro
    • San Marcos, California, United States, 92078
      • Kaiser Permanente-San Marcos
    • San Rafael, California, United States, 94903
      • Kaiser San Rafael-Gallinas
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center - Santa Clara
    • Santa Rosa, California, United States, 95403
      • Kaiser Permanente-Santa Rosa
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente-South San Francisco
    • Stockton, California, United States, 95210
      • Kaiser Permanente-Stockton
    • Vacaville, California, United States, 95688
      • Kaiser Permanente Medical Center-Vacaville
    • Vallejo, California, United States, 94589
      • Kaiser Permanente-Vallejo
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente-Walnut Creek
    • Woodland Hills, California, United States, 91367
      • Kaiser Permanente-Woodland Hills
  • Colorado
    • Denver, Colorado, United States, 80205
      • Kaiser Permanente-Franklin
    • Lafayette, Colorado, United States, 80026
      • Kaiser Permanente-Rock Creek
    • Lone Tree, Colorado, United States, 80124
      • Kaiser Permanente-Lone Tree
  • Delaware
    • Millville, Delaware, United States, 19967
      • Beebe South Coastal Health Campus
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants PA
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System-Christiana Hospital
    • Rehoboth Beach, Delaware, United States, 19971
      • Beebe Health Campus
    • Wilmington, Delaware, United States, 19801
      • Christiana Care Health System-Wilmington Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • Columbus, Georgia, United States, 31904
      • John B Amos Cancer Center
    • Duluth, Georgia, United States, 30096
      • Northside Hospital - Duluth
    • Lawrenceville, Georgia, United States, 30046
      • Northside Hospital - Gwinnett
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Snellville, Georgia, United States, 30078
      • Suburban Hematology Oncology Associates - Snellville
    • Tifton, Georgia, United States, 31794
      • Tift Regional Medical Center
    • Valdosta, Georgia, United States, 31602
      • South Georgia Medical Center/Pearlman Cancer Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Moanalua Medical Center
  • Illinois
    • Alton, Illinois, United States, 62002
      • OSF Saint Anthony's Health Center
    • Bloomington, Illinois, United States, 61704
      • Illinois CancerCare-Bloomington
    • Canton, Illinois, United States, 61520
      • Illinois CancerCare-Canton
    • Carbondale, Illinois, United States, 62902
      • Memorial Hospital of Carbondale
    • Carterville, Illinois, United States, 62918
      • SIH Cancer Institute
    • Carthage, Illinois, United States, 62321
      • Illinois CancerCare-Carthage
    • Centralia, Illinois, United States, 62801
      • Centralia Oncology Clinic
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr Hospital of Cook County
    • Danville, Illinois, United States, 61832
      • Carle at The Riverfront
    • Decatur, Illinois, United States, 62526
      • Cancer Care Specialists of Illinois - Decatur
    • Dixon, Illinois, United States, 61021
      • Illinois CancerCare-Dixon
    • Effingham, Illinois, United States, 62401
      • Crossroads Cancer Center
    • Eureka, Illinois, United States, 61530
      • Illinois CancerCare-Eureka
    • Galesburg, Illinois, United States, 61401
      • Illinois CancerCare-Galesburg
    • Kewanee, Illinois, United States, 61443
      • Illinois CancerCare-Kewanee Clinic
    • Macomb, Illinois, United States, 61455
      • Illinois CancerCare-Macomb
    • Mattoon, Illinois, United States, 61938
      • Carle Physician Group-Mattoon/Charleston
    • O'Fallon, Illinois, United States, 62269
      • Cancer Care Center of O'Fallon
    • Ottawa, Illinois, United States, 61350
      • Illinois CancerCare-Ottawa Clinic
    • Pekin, Illinois, United States, 61554
      • Illinois CancerCare-Pekin
    • Peoria, Illinois, United States, 61615
      • Illinois CancerCare-Peoria
    • Peru, Illinois, United States, 61354
      • Illinois CancerCare-Peru
    • Princeton, Illinois, United States, 61356
      • Illinois CancerCare-Princeton
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic
    • Springfield, Illinois, United States, 62781
      • Springfield Memorial Hospital
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
    • Washington, Illinois, United States, 61571
      • Illinois CancerCare - Washington
  • Kansas
    • Garden City, Kansas, United States, 67846
      • Central Care Cancer Center - Garden City
    • Hays, Kansas, United States, 67601
      • HaysMed
    • Lawrence, Kansas, United States, 66044
      • Lawrence Memorial Hospital
    • Olathe, Kansas, United States, 66061
      • The University of Kansas Cancer Center - Olathe
    • Overland Park, Kansas, United States, 66210
      • University of Kansas Cancer Center-Overland Park
    • Salina, Kansas, United States, 67401
      • Salina Regional Health Center
    • Topeka, Kansas, United States, 66606
      • University of Kansas Health System Saint Francis Campus
    • Westwood, Kansas, United States, 66205
      • University of Kansas Hospital-Westwood Cancer Center
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Christus Saint Frances Cabrini Hospital
    • Baton Rouge, Louisiana, United States, 70805
      • LSU Health Baton Rouge-North Clinic
    • Baton Rouge, Louisiana, United States, 70809
      • Louisiana Hematology Oncology Associates LLC
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • Baton Rouge, Louisiana, United States, 70816
      • Medical Center of Baton Rouge
    • Baton Rouge, Louisiana, United States, 70836
      • Ochsner High Grove
    • Baton Rouge, Louisiana, United States, 70817
      • Our Lady of the Lake Medical Oncology
    • Baton Rouge, Louisiana, United States, 70817
      • Louisiana Hematology Oncology Associates
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Physician Group
    • Baton Rouge, Louisiana, United States, 70809
      • MBP Cancer Center - Baton Rouge General
    • Covington, Louisiana, United States, 70433
      • Mary Bird Perkins Cancer Center - Covington
    • Covington, Louisiana, United States, 70433
      • Northshore Oncology Associates-Covington
    • Covington, Louisiana, United States, 70433
      • Ochsner Hematology Oncology North Shore - Covington (West Region)
    • Houma, Louisiana, United States, 70360
      • Terrebonne General Medical Center
    • Kenner, Louisiana, United States, 70065
      • Ochsner Medical Center Kenner
    • Lafayette, Louisiana, United States, 70503
      • Cancer Center of Acadiana
    • Marrero, Louisiana, United States, 70072
      • West Jefferson Medical Center
    • Monroe, Louisiana, United States, 71202
      • Ochsner LSU Health Monroe Medical Center
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center Jefferson
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Baptist Medical Center
    • Shreveport, Louisiana, United States, 71103
      • LSU Health Sciences Center at Shreveport
  • Maryland
    • Elkton, Maryland, United States, 21921
      • Christiana Care - Union Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
    • Brighton, Michigan, United States, 48114
      • Trinity Health Medical Center - Brighton
    • Canton, Michigan, United States, 48188
      • Trinity Health Medical Center - Canton
    • Chelsea, Michigan, United States, 48118
      • Chelsea Hospital
    • Flint, Michigan, United States, 48503
      • Genesee Hematology Oncology PC
    • Flint, Michigan, United States, 48503
      • Genesys Hurley Cancer Institute
    • Flint, Michigan, United States, 48503
      • Cancer Hematology Centers - Flint
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
    • Livonia, Michigan, United States, 48154
      • Trinity Health Saint Mary Mercy Livonia Hospital
    • Muskegon, Michigan, United States, 49444
      • Trinity Health Muskegon Hospital
    • Norton Shores, Michigan, United States, 49444
      • Cancer and Hematology Centers of Western Michigan - Norton Shores
    • Pontiac, Michigan, United States, 48341
      • Trinity Health Saint Joseph Mercy Oakland Hospital
    • Reed City, Michigan, United States, 49677
      • Corewell Health Reed City Hospital
    • Wyoming, Michigan, United States, 49519
      • University of Michigan Health - West
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minnesota Oncology - Burnsville
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Fridley, Minnesota, United States, 55432
      • Unity Hospital
    • Maple Grove, Minnesota, United States, 55369
      • Fairview Clinics and Surgery Center Maple Grove
    • Maplewood, Minnesota, United States, 55109
      • Saint John's Hospital - Healtheast
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology PA-Maplewood
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Minneapolis, Minnesota, United States, 55407
      • Abbott-Northwestern Hospital
    • Monticello, Minnesota, United States, 55362
      • Monticello Cancer Center
    • New Ulm, Minnesota, United States, 56073
      • New Ulm Medical Center
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Health Center
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic - Saint Louis Park
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
    • Shakopee, Minnesota, United States, 55379
      • Saint Francis Regional Medical Center
    • Stillwater, Minnesota, United States, 55082
      • Lakeview Hospital
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Willmar, Minnesota, United States, 56201
      • Rice Memorial Hospital
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology PA-Woodbury
    • Wyoming, Minnesota, United States, 55092
      • Fairview Lakes Medical Center
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Baptist Memorial Hospital and Cancer Center-Golden Triangle
    • Grenada, Mississippi, United States, 38901
      • Baptist Cancer Center-Grenada
    • Gulfport, Mississippi, United States, 39502
      • Gulfport Memorial Hospital
    • Jackson, Mississippi, United States, 39202
      • Jackson Oncology Associates PLLC
    • Jackson, Mississippi, United States, 39202
      • Mississippi Baptist Medical Center
    • New Albany, Mississippi, United States, 38652
      • Baptist Memorial Hospital and Cancer Center-Union County
    • Oxford, Mississippi, United States, 38655
      • Baptist Memorial Hospital and Cancer Center-Oxford
    • Southhaven, Mississippi, United States, 38671
      • Baptist Memorial Hospital and Cancer Center-Desoto
  • Missouri
    • Farmington, Missouri, United States, 63640
      • Parkland Health Center - Farmington
    • Jefferson City, Missouri, United States, 65109
      • MU Health Care Goldschmidt Cancer Center
    • Joplin, Missouri, United States, 64804
      • Freeman Health System
    • Kansas City, Missouri, United States, 64154
      • University of Kansas Cancer Center - North
    • Kansas City, Missouri, United States, 64108
      • University Health Truman Medical Center
    • Lee's Summit, Missouri, United States, 64064
      • University of Kansas Cancer Center - Lee's Summit
    • North Kansas City, Missouri, United States, 64116
      • University of Kansas Cancer Center at North Kansas City Hospital
    • Sainte Genevieve, Missouri, United States, 63670
      • Sainte Genevieve County Memorial Hospital
    • St Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • St Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
    • Sullivan, Missouri, United States, 63080
      • Missouri Baptist Sullivan Hospital
    • Sunset Hills, Missouri, United States, 63127
      • BJC Outpatient Center at Sunset Hills
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive Cancer Centers of Nevada - Henderson
    • Henderson, Nevada, United States, 89052
      • OptumCare Cancer Care at Seven Hills
    • Henderson, Nevada, United States, 89074
      • Comprehensive Cancer Centers of Nevada-Southeast Henderson
    • Henderson, Nevada, United States, 89074
      • Urology Specialists of Nevada - Green Valley
    • Las Vegas, Nevada, United States, 89144
      • Summerlin Hospital Medical Center
    • Las Vegas, Nevada, United States, 89102
      • OptumCare Cancer Care at Charleston
    • Las Vegas, Nevada, United States, 89128
      • Comprehensive Cancer Centers of Nevada - Northwest
    • Las Vegas, Nevada, United States, 89128
      • OptumCare Cancer Care at MountainView
    • Las Vegas, Nevada, United States, 89135
      • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
    • Las Vegas, Nevada, United States, 89144
      • Comprehensive Cancer Centers of Nevada - Town Center
    • Las Vegas, Nevada, United States, 89144
      • Comprehensive Cancer Centers of Nevada-Summerlin
    • Las Vegas, Nevada, United States, 89148
      • OptumCare Cancer Care at Fort Apache
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada - Central Valley
    • Las Vegas, Nevada, United States, 89128
      • Urology Specialists of Nevada - Northwest
    • Las Vegas, Nevada, United States, 89113
      • Urology Specialists of Nevada - Southwest
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • AdventHealth Infusion Center Asheville
    • Clyde, North Carolina, United States, 28721
      • AdventHealth Infusion Center Haywood
    • Gastonia, North Carolina, United States, 28054
      • CaroMont Regional Medical Center
    • Hendersonville, North Carolina, United States, 28792
      • AdventHealth Hendersonville
    • New Bern, North Carolina, United States, 28561
      • CarolinaEast Medical Center
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth of the Carolinas-Moore Regional Hospital
    • Weaverville, North Carolina, United States, 28787
      • AdventHealth Infusion Center Weaverville
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Indu and Raj Soin Medical Center
    • Findlay, Ohio, United States, 45840
      • Armes Family Cancer Center
    • Franklin, Ohio, United States, 45005
      • Dayton Physicians LLC-Atrium
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Hospital Oklahoma City
  • Oregon
    • Newberg, Oregon, United States, 97132
      • Providence Newberg Medical Center
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
    • Portland, Oregon, United States, 97225
      • Providence Saint Vincent Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital-Cedar Crest
    • Bethlehem, Pennsylvania, United States, 18017
      • Lehigh Valley Hospital - Muhlenberg
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health Cancer Center
    • Beaufort, South Carolina, United States, 29902
      • Beaufort Memorial Hospital
    • Bluffton, South Carolina, United States, 29910
      • Saint Joseph's/Candler - Bluffton Campus
    • Boiling Springs, South Carolina, United States, 29316
      • Prisma Health Cancer Institute - Spartanburg
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Easley, South Carolina, United States, 29640
      • Prisma Health Cancer Institute - Easley
    • Gaffney, South Carolina, United States, 29341
      • Gibbs Cancer Center-Gaffney
    • Georgetown, South Carolina, United States, 29440
      • Tidelands Georgetown Memorial Hospital
    • Georgetown, South Carolina, United States, 29440
      • Waccamaw Oncology - Georgetown
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Faris
    • Greenville, South Carolina, United States, 29607
      • Saint Francis Cancer Center
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute - Eastside
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Butternut
    • Greenville, South Carolina, United States, 29601
      • Saint Francis Hospital
    • Greenwood, South Carolina, United States, 29646
      • Self Regional Healthcare
    • Greer, South Carolina, United States, 29650
      • Prisma Health Cancer Institute - Greer
    • Greer, South Carolina, United States, 29651
      • Gibbs Cancer Center-Pelham
    • Hilton Head Island, South Carolina, United States, 29926-3827
      • South Carolina Cancer Specialists PC
    • Murrells Inlet, South Carolina, United States, 29576
      • Waccamaw Oncology-Murrells Inlet
    • Myrtle Beach, South Carolina, United States, 29577
      • Waccamaw Oncology-Myrtle Beach
    • Okatie, South Carolina, United States, 29909
      • Beaufort Memorial/New River Cancer Center
    • Seneca, South Carolina, United States, 29672
      • Prisma Health Cancer Institute - Seneca
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
    • Union, South Carolina, United States, 29379
      • SMC Center for Hematology Oncology Union
  • Tennessee
    • Collierville, Tennessee, United States, 38017
      • Baptist Memorial Hospital and Cancer Center-Collierville
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital and Cancer Center-Memphis
  • Virginia
    • Mechanicsville, Virginia, United States, 23116
      • Bon Secours Memorial Regional Medical Center
    • Midlothian, Virginia, United States, 23114
      • Bon Secours Saint Francis Medical Center
    • Midlothian, Virginia, United States, 23113
      • Bon Secours Westchester Emergency Center
    • Richmond, Virginia, United States, 23226
      • Bon Secours Saint Mary's Hospital
    • Richmond, Virginia, United States, 23230
      • Bon Secours Cancer Institute at Reynolds Crossing
  • Washington
    • Renton, Washington, United States, 98055
      • Valley Medical Center
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • ThedaCare Regional Cancer Center
    • Appleton, Wisconsin, United States, 54915
      • Ascension Saint Elizabeth Hospital
    • Berlin, Wisconsin, United States, 54923
      • ThedaCare Cancer Care - Berlin
    • Brookfield, Wisconsin, United States, 53045
      • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
    • Chilton, Wisconsin, United States, 53014
      • Ascension Calumet Hospital
    • Eau Claire, Wisconsin, United States, 54701
      • HSHS Sacred Heart Hospital
    • Franklin, Wisconsin, United States, 53132
      • Ascension Saint Francis - Reiman Cancer Center
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital Cancer Center Green Bay
    • Green Bay, Wisconsin, United States, 54303
      • Saint Vincent Hospital Cancer Center at Saint Mary's
    • Mequon, Wisconsin, United States, 53097
      • Ascension Columbia Saint Mary's Hospital Ozaukee
    • Milwaukee, Wisconsin, United States, 53211
      • Ascension Columbia Saint Mary's Hospital - Milwaukee
    • Neenah, Wisconsin, United States, 54956
      • ThedaCare Regional Medical Center - Neenah
    • New London, Wisconsin, United States, 54961
      • ThedaCare Cancer Care - New London
    • New Richmond, Wisconsin, United States, 54017
      • Cancer Center of Western Wisconsin
    • Oshkosh, Wisconsin, United States, 54904
      • Ascension Mercy Hospital
    • Oshkosh, Wisconsin, United States, 54904
      • ThedaCare Cancer Care - Oshkosh
    • Racine, Wisconsin, United States, 53405
      • Ascension All Saints Hospital
    • Shawano, Wisconsin, United States, 54166
      • ThedaCare Cancer Care - Shawano
    • Waupaca, Wisconsin, United States, 54981
      • ThedaCare Cancer Care - Waupaca
    • Wauwatosa, Wisconsin, United States, 53226
      • Ascension Medical Group Southeast Wisconsin - Mayfair Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

African American or European American patients diagnosed with stage I-IV invasive cancer receiving immune checkpoint inhibitor treatment

Description

Inclusion Criteria:

• Be 18 years of age or older

• Self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA)

  • Patients may identify a Hispanic/Latino ethnicity in combination with an AA or EA racial identity

• Have a current diagnosis of invasive cancer at stage I-IV

  • Patients may have a history of previous cancer diagnosis and cancer treatment not involving immunotherapy
• Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy alone or in combination with co-treatments (including alternative ICIs)
• Be able to speak and read English or Spanish
• Be able to provide informed consent

Exclusion Criteria:

• Identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• Be diagnosed with melanoma (because melanoma is very rare in AAs)
• Currently participate in any trials of a cancer therapeutic nature; participation in noninterventional trial, or trials of symptom control or supportive nature is allowed; participation in future cancer therapeutic trials after completing the A2 assessment (e.g., after the second infusion of ICIs) is also allowed
• Have received prior immunotherapy for cancer, including checkpoint inhibitors, chimeric antigen receptor (CAR)-T therapy, cytokine therapy, and/or Bacillus Calmette-Guerin (BCG) for bladder cancer

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (questionnaire, biospecimen, medical records)); Patients complete questionnaires and undergo collection of blood, saliva and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Complete questionnaires; Other: Electronic Health Record Review; Review of medical records; Other: Interview; Complete an interview; Procedure: Biospecimen Collection; Undergo collection of tumor, blood, saliva and stool samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Racial differences in the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs)	Will be evaluated in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.	Within 1 year after starting immune checkpoint inhibitor (ICI) treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Racial differences in overall response rate (ORR) between African American (AA) and European American (EA) patients	Multivariable modeling will be conducted to adjust for covariates.	Within 1 year after starting ICI treatment
Health-related quality of life (HRQOL) - PROPr	Will be assessed by Patient Reported Outcomes Preference (PROPr). This is a T-score with a mean of 50 and a standard deviation of 0.	Within 1 year after starting ICI treatment
Health-related quality of life (HRQOL) - FACT-ICM	Will be assessed by Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM), which is a count of symptoms.	Within 1 year after starting ICI treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity and timing of immune-related adverse events (irAEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE)	Severity and timing of grade 2-5 immune-related adverse events (irAEs) will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Racial differences in irAE rates will be assessed in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.	Within 1 year after starting ICI treatment
Progression-free survival	Two sample t-test or Wilcoxon rank test will be conducted for continuous outcomes. Log-rank test will be used to evaluate between group (AA versus [vs.] AE) for time-dependent variables. Multivariable Cox regression will be conducted to adjust for imbalance in covariates.	Up to 4 years
Health related quality of life (HRQOL) since ICI treatment at the end of the study periodHealth-related quality of life (HRQOL) measured using the PROMIS-Preference (PROPr) summary score at the end of the study period	Will be examined at the end of the study period (up to 4 years) using a two sample t-test to compare racial groups.	Up to 4 years
Treatment delay and discontinuation	Treatment delay is defined as time lapse between two consecutive infusion cycles >4 weeks (yes/no), and discontinuation as permanently holding further administration of ICI immunotherapy due to toxicities or disease progression in the metastatic setting, or total infusion cycles of ICIs fewer than that recommended according to National Comprehensive Cancer Network (NCCN) guidelines as a result of premature termination due to toxicities in the adjuvant setting (yes/no).	Within 1 year after starting ICI treatment

Collaborators and Investigators

• Sponsor: University of Rochester NCORP Research Base
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Charles Kamen, PhD, University of Rochester NCORP Research Base

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Specimen Handling
• Other Study ID Numbers: URCC21038 (Other Identifier: University of Rochester NCORP Research Base); UG1CA189961 (U.S. NIH Grant/Contract); NCI-2022-01426 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); URCC-21038 (Other Identifier: CTEP); UH3CA260602 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No