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NCT Number: NCT05863052

Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

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.

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Key information

Conditions

Immune Checkpoint Inhibitors Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Metastatic Solid Tumor Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nonsmall Cell Lung Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Cancer Center at the Unvieristy of Arizona, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunotherapy

Biological

immunotherapy

Primary outcomes

  1. Progression Free Survival

    Time frame: 1 year

    Evaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy

  2. Overall Survival Benefit

    Time frame: 1 year

    Evaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy

  3. Treatment related Adverse Events

    Time frame: 1 year

    Evaluating treatment related adverse events of American Indian population vs. white population who were treated with immunotherapy

Secondary outcomes

  1. Difference in cancer related mortality

    Time frame: 1 year

    Evaluate the difference in cancer related mortality in American Indian populations vs white

Other outcomes

  1. Tumor mutational burden

    Time frame: 1 year

    Describe the differences in tumor mutational burden (TMB) between the American Indian population vs Whites or Black Americans

  2. Somatic genetic variants

    Time frame: 1 year

    Describe the somatic genetic variants differences between the American Indian population vs Whites or Black Americans

  3. Demographic differences

    Time frame: 1 year

    Describe the demographics differences between the American Indian population vs Whites or Black Americans

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 17, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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