Cancer
URCC 21038: An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study
Description
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.
Inclusion Notes
For a full description of this trial, please go to the listing on www.clinicaltrials.gov
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 AAor EA racial identity
- Have a current diagnosis of invasive cancer at stage I-V
- 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 according to Food and Drug Administration (FDA) labels or National Comprehensive Cancer Network (NCCN)guidelines at Category 1 or 2A as standard of care treatment alone or in combination with co-treatments (including alternative ICIs)
- Be able to speak and read English or Spanish
- Be able to work written or remote 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 or plan to participate in any other cancer treatment trials
- Have received prior immunotherapy for cancer, including checkpoint inhibitors, chimeric antigen receptor (CAR)- T therapy, and/or cytokine therapy
Start Date
Monday, July 11, 2022
Principal / Contact Name
Mark A. Taylor, MD