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Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population Treated With Immune Checkpoint Inhibitors for Various Cancers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05863052
Enrollment
72
Registered
2023-05-17
Start date
2022-01-31
Completion date
2027-12-31
Last updated
2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Cancer, Immune Checkpoint Inhibitors, Melanoma, Metastatic Solid Tumor, Nonsmall Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma

Brief summary

The aim of this study is to describe the outcomes in American Indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

Detailed description

Immune checkpoint inhibitors have been shown to increase survival in metastatic solid tumor patients when compared to the previously standard of care chemotherapy. Epidemiologic studies of American Indian cancer patients demonstrated having significantly worse survival when compared with Caucasians when controlled for age, sex, alcohol abuse, smoking, insurance, and disease stage. There are no current studies specifically examining the American Indian population receiving treatment with immune checkpoint inhibitors. The aim is to describe the outcomes in American Indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

Interventions

BIOLOGICALImmunotherapy

immunotherapy

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* above age 18, * histologically and cytologically confirmed NSCLC, melanoma, head and neck squamous cell carcinoma, gastrointestinal cancers,, renal cell carcinoma, or any other solid tumors where immune checkpoint therapy has been used * received immunotherapy as part of their treatment * Self-identified American Indian in ethnicity * Patients at the Stephenson Cancer Center between 2015 to 2021

Exclusion criteria

* patients who did not receive immune checkpoint inhibitor therapy

Design outcomes

Primary

MeasureTime frameDescription
Progression Free Survival1 yearEvaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy
Overall Survival Benefit1 yearEvaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy
Treatment related Adverse Events1 yearEvaluating treatment related adverse events of American Indian population vs. white population who were treated with immunotherapy

Secondary

MeasureTime frameDescription
Difference in cancer related mortality1 yearEvaluate the difference in cancer related mortality in American Indian populations vs white

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAbdul Naqash, MD

University of Oklahoma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026