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

September 16, 2026 updated by: University of Oklahoma

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 1 year
Evaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy
1 year
Overall Survival Benefit
Time Frame: 1 year
Evaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy
1 year
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
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 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)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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