Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Biological: Immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| American Indian population<br> | Biological: Immunotherapy<br>* immunotherapy<br>|
| Caucasians treated with immunotherapy<br> | Biological: Immunotherapy<br>* immunotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Evaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy | 1 year | 
| Overall Survival Benefit | Evaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy | 1 year | 
| Treatment related Adverse Events | Evaluating treatment related adverse events of American Indian population vs. white population who were treated with immunotherapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in cancer related mortality | Evaluate the difference in cancer related mortality in American Indian populations vs white | 1 year |