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

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. 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.

Eligibility

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

Conditions3

Locations259 sites

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