🏛️ Verified NIH Record • Updated 2026-03-11

An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study (NCT05364086)

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

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: University of Rochester NCORP Research Base

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (5 items).

Location: NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas

Age range: 18 Years

🧪 Interventions in This Study

  • Biospecimen Collection (PROCEDURE)
  • Electronic Health Record Review (OTHER)
  • Interview (OTHER)
  • Quality-of-Life Assessment (OTHER)
  • Questionnaire Administration (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (259 Sites)

Showing the first 25 of 259 sites.

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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗