AzTrials
AzTrials

Hematopoietic and Lymphoid Cell NeoplasmDiRECTNCT05364086

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

An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by University of Rochester NCORP Research Base at 259 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Electronic Health Record Review and Interview
How many people
2,100 participants
Where
259 sitesUnited States
Study dates
26 Apr 2022to 31 Jan 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

259 sites in 1 country.

259 sites in 1 country

United States259 sites

  • Christus Saint Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • MBP Cancer Center - Baton Rouge General

    Baton Rouge, Louisiana, 70809

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Louisiana Hematology Oncology Associates

    Baton Rouge, Louisiana, 70817

  • Our Lady of the Lake Medical Oncology

    Baton Rouge, Louisiana, 70817

  • Ochsner High Grove

    Baton Rouge, Louisiana, 70836

  • Beaufort Memorial Hospital

    Beaufort, South Carolina, 29902

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • ThedaCare Cancer Care - Berlin

    Berlin, Wisconsin, 54923

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Ascension Calumet Hospital

    Chilton, Wisconsin, 53014

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

  • Northshore Oncology Associates-Covington

    Covington, Louisiana, 70433

  • Ochsner Hematology Oncology North Shore - Covington (West Region)

    Covington, Louisiana, 70433

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Ascension Saint Francis - Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Waccamaw Oncology - Georgetown

    Georgetown, South Carolina, 29440

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Gulfport Memorial Hospital

    Gulfport, Mississippi, 39502

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

  • HaysMed

    Hays, Kansas, 67601

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada, 89074

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina, 29926-3827

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Jackson Oncology Associates PLLC

    Jackson, Mississippi, 39202

  • Mississippi Baptist Medical Center

    Jackson, Mississippi, 39202

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Freeman Health System

    Joplin, Missouri, 64804

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • Ochsner Medical Center Kenner

    Kenner, Louisiana, 70065

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado, 80026

  • Cancer Center of Acadiana

    Lafayette, Louisiana, 70503

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada, 89113

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada, 89128

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Kaiser Permanente-Lone Tree

    Lone Tree, Colorado, 80124

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • West Jefferson Medical Center

    Marrero, Louisiana, 70072

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Bon Secours Memorial Regional Medical Center

    Mechanicsville, Virginia, 23116

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Ascension Columbia Saint Mary's Hospital Ozaukee

    Mequon, Wisconsin, 53097

  • Bon Secours Westchester Emergency Center

    Midlothian, Virginia, 23113

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Ascension Columbia Saint Mary's Hospital - Milwaukee

    Milwaukee, Wisconsin, 53211

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • Ochsner LSU Health Monroe Medical Center

    Monroe, Louisiana, 71202

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Waccamaw Oncology-Murrells Inlet

    Murrells Inlet, South Carolina, 29576

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

  • Waccamaw Oncology-Myrtle Beach

    Myrtle Beach, South Carolina, 29577

  • ThedaCare Regional Medical Center - Neenah

    Neenah, Wisconsin, 54956

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

  • CarolinaEast Medical Center

    New Bern, North Carolina, 28561

  • ThedaCare Cancer Care - New London

    New London, Wisconsin, 54961

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • Beaufort Memorial/New River Cancer Center

    Okatie, South Carolina, 29909

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • Ascension Mercy Hospital

    Oshkosh, Wisconsin, 54904

  • ThedaCare Cancer Care - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Ascension All Saints Hospital

    Racine, Wisconsin, 53405

  • Kaiser Permanente- Marshall Medical Offices

    Redwood City, California, 94063

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Valley Medical Center

    Renton, Washington, 98055

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Bon Secours Saint Mary's Hospital

    Richmond, Virginia, 23226

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • University of Rochester

    Rochester, New York, 14642

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • ThedaCare Cancer Care - Shawano

    Shawano, Wisconsin, 54166

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Suburban Hematology Oncology Associates - Snellville

    Snellville, Georgia, 30078

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Kaiser Permanente-Stockton

    Stockton, California, 95210

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127

  • Tift Regional Medical Center

    Tifton, Georgia, 31794

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • SMC Center for Hematology Oncology Union

    Union, South Carolina, 29379

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, 95688

  • South Georgia Medical Center/Pearlman Cancer Center

    Valdosta, Georgia, 31602

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • ThedaCare Cancer Care - Waupaca

    Waupaca, Wisconsin, 54981

  • Ascension Medical Group Southeast Wisconsin - Mayfair Road

    Wauwatosa, Wisconsin, 53226

  • AdventHealth Infusion Center Weaverville

    Weaverville, North Carolina, 28787

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Christiana Care Health System-Wilmington Hospital

    Wilmington, Delaware, 19801

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Kaiser Permanente-Woodland Hills

    Woodland Hills, California, 91367

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

  1. 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.

Being tested
Biospecimen Collection, Electronic Health Record Review, Interview, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of tumor, blood, saliva and stool samples

  • Electronic Health Record ReviewOther

    Review of medical records

  • InterviewOther

    Complete an interview

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Complete questionnaires

Study groups in NCT05364086
Study groupRoleWhat they receive
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.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 1 year after starting immune checkpoint inhibitor (ICI) treatment

Secondary outcomes (3)

  1. 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.

    Measured: Within 1 year after starting ICI treatment

  2. 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.

    Measured: Within 1 year after starting ICI treatment

  3. 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.

    Measured: Within 1 year after starting ICI treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start26 Apr 2022
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05364086
Sponsor's protocol ID
URCC21038
Other IDs
NCI-2022-01426, URCC21038, URCC-21038, URCC-21038, UG1CA189961, UH3CA260602
Acronym
DiRECT
Status last verified
Mar 2026
First submitted
31 Mar 2022
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by University of Rochester NCORP Research Base at 259 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 259 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Racial differences in the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs) (time frame: Within 1 year after starting immune checkpoint inhibitor (ICI) treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05364086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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