Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study
NCT05364086 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Electronic Health Record Review
- OTHER Interview
Study Locations (20)
California
- Kaiser Permanente-Anaheim — Anaheim
- Kaiser Permanente-Deer Valley Medical Center — Antioch
- Kaiser Permanente-Baldwin Park — Baldwin Park
- Kaiser Permanente-Bellflower — Bellflower
- Kaiser Permanente Dublin — Dublin
- Kaiser Permanente-Fontana — Fontana
- Kaiser Permanente-Fremont — Fremont
- Kaiser Permanente-Fresno — Fresno
- Kaiser Permanente South Bay — Harbor City
- Kaiser Permanente-Irvine — Irvine
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Kaiser Permanente West Los Angeles — Los Angeles
- Kaiser Permanente-Modesto — Modesto
- Kaiser Permanente-Oakland — Oakland
- Kaiser Permanente-Ontario — Ontario
- Kaiser Permanente - Panorama City — Panorama City
- Kaiser Permanente- Marshall Medical Offices — Redwood City
- Kaiser Permanente-Richmond — Richmond
- Kaiser Permanente-Riverside — Riverside
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,100 participants |
| Start Date | 2022-04-26 |
| Est. Completion | 2030-01-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05364086
The ClinicalTrials.gov registry entry for NCT05364086 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester NCORP Research Base, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05364086 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05364086 about?
NCT05364086 is a clinical study titled "An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study". 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 patie...
What is the current status of trial NCT05364086?
This trial is currently active not recruiting. The enrollment target is 2,100 participants. The study started on 2022-04-26. Estimated completion is 2030-01-31.
What conditions does trial NCT05364086 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05364086?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Electronic Health Record Review (OTHER), Interview (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05364086?
This trial is sponsored by University of Rochester NCORP Research Base, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05364086 being conducted?
This trial has 20 study locations across Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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