Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population (SCC-ClinO+Ge)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma; Renal Cell Carcinoma; Nonsmall Cell Lung Cancer; Metastatic Solid Tumor; Gastrointestinal Cancer; Immune Checkpoint Inhibitors; Squamous Cell Carcinoma
• Intervention / Treatment: Biological: Immunotherapy

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.

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Arizona Cancer Center at the Unvieristy of Arizona
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Comprehensive Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • Stephenson Cancer Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Cancer Care Institute
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at the University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

American Indian population is the primary group of interest for this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
American Indian population	Biological: Immunotherapy; immunotherapy
Caucasians treated with immunotherapy	Biological: Immunotherapy; immunotherapy

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor mutational burden	Describe the differences in tumor mutational burden (TMB) between the American Indian population vs Whites or Black Americans	1 year
Somatic genetic variants	Describe the somatic genetic variants differences between the American Indian population vs Whites or Black Americans	1 year
Demographic differences	Describe the demographics differences between the American Indian population vs Whites or Black Americans	1 year

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Abdul Naqash, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Skin Diseases; Urologic Neoplasms; Carcinoma; Neoplasms, Squamous Cell; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Neoplasm Metastasis; Gastrointestinal Neoplasms; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Melanoma; Therapeutics; Biological Therapy; Immunomodulation; Immunotherapy
• Other Study ID Numbers: OU-SCC-ClinO+GenD; BAA PMWP 213 (Other Grant/Funding Number: FDA); OU202111ARN-OKAMERICANINDIAN (Other Identifier: OUHSC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No