Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

Active, not recruiting

• Conditions: Renal Cell Carcinoma; Immune Checkpoint Inhibitors; Melanoma; Gastrointestinal Cancer; Squamous Cell Carcinoma; Metastatic Solid Tumor; Nonsmall Cell Lung Cancer
• Interventions: Biological: Immunotherapy

• Registration Number: NCT05863052
• Lead Sponsor: University of Oklahoma

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.

Study Timeline

• Study Start: 2022-01-31
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caucasians treated with immunotherapy	Immunotherapy	-
American Indian population	Immunotherapy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Difference in cancer related mortality	1 year	Evaluate the difference in cancer related mortality in American Indian populations vs white

Trial Locations

Locations (6)

University of New Mexico Comprehensive Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

Monument Health Cancer Care Institute; 🇺🇸 Rapid City, South Dakota, United States

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Huntsman Cancer Institute at the University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Arizona Cancer Center at the Unvieristy of Arizona; 🇺🇸 Tucson, Arizona, United States