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

Running, not enrolling

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT05364086

Run by

University of Rochester NCORP Research Base

People needed

2100

Starts

2022-04-26

Expected to finish

2030-01-31

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Kaiser Permanente Dublin — Dublin, California, United States
• Kaiser Permanente-Fontana — Fontana, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Kaiser Permanente-Fresno — Fresno, California, United States
• Kaiser Permanente South Bay — Harbor City, California, United States
• Kaiser Permanente-Irvine — Irvine, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Kaiser Permanente West Los Angeles — Los Angeles, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Kaiser Permanente-Ontario — Ontario, California, United States
• Kaiser Permanente - Panorama City — Panorama City, California, United States
• Kaiser Permanente- Marshall Medical Offices — Redwood City, California, United States
• Kaiser Permanente-Richmond — Richmond, California, United States
• Kaiser Permanente-Riverside — Riverside, California, United States
• Kaiser Permanente-Roseville — Roseville, California, United States
• Kaiser Permanente Downtown Commons — Sacramento, California, United States
• Kaiser Permanente-South Sacramento — Sacramento, California, United States
• Kaiser Permanente-San Diego Mission — San Diego, California, United States
• Kaiser Permanente-San Diego Zion — San Diego, California, United States
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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