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

Cancer Type
Hematopoietic Malignancies
Solid Tumor
Trial Phase
18 Years and older, Male and Female
Study Type
Health services research
Protocol IDs
URCC21038 (primary)
Study Sponsor
University of Rochester NCORP Research Base


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.


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.

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.

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.

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.


  1. Be 18 years of age or older
  2. 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
  3. 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
  4. Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy alone or in combination with co-treatments (including alternative ICIs)
  5. Be able to speak and read English or Spanish
  6. Be able to provide written or remote informed consent

Treatment Sites in Georgia

Atlanta Cancer Care - Alpharetta

3400 C Old Milton Parkway
Suite 400
Alpharetta, GA 30005

Atlanta Cancer Care - Conyers

1498 Klondike Road
Suite 106
Conyers, GA 30094

Atlanta Cancer Care - Cumming

1505 Northside Boulevard
Suite 4600
Cumming, GA 30041
770-205-5292 x1041

Atlanta Cancer Care - Decatur

2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033

Atlanta Cancer Care - Stockbridge

7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069

Atlanta Cancer Care - Tower

5670 Peachtree Dunwoody Road
Suite 1100
Atlanta, GA 30342

Atlanta Gynecologic Oncology

980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342

Atlanta Head and Neck Associates

960 Johnson Ferry Road NE
Suite 335
Atlanta, GA 30342

Georgia Cancer Specialists - Athens

125 King Avenue
Suite 200
Athens, GA 30606

Georgia Cancer Specialists - Canton

228 Riverstone Drive
Canton, GA 30114

Georgia Cancer Specialists - CenterPointe

1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242

Georgia Cancer Specialists - Kennestone

790 Church Street
Suite 335
Marietta, GA 30060

Georgia Cancer Specialists - Macon-Coliseum

308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152

Georgia Cancer Specialists - Stemmer

2712 Lawrenceville Highway
Decatur, GA 30033

Georgia Gynecologic Oncology

980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342

John B Amos Cancer Center

1831 Fifth Avenue
Columbus, GA 31904

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342

Northside Hospital Cancer Institute - Forsyth

1200 Northside Forsyth Drive
Suite 140
Cumming, GA 30041

Pearlman Cancer Center at South Georgia Medical Center

2501 North Patterson Street
Valdosta, GA 31602

University Gynecologic Oncology

960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.