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NCT05863052 Clinical Trial

Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05863052
Other study ID # OU-SCC-ClinO+GenD
Secondary ID BAA PMWP 213OU20
Status Active, not recruiting
Phase
First received
Last updated
Start date January 31, 2022
Est. completion date July 2026

Study information
Verified date April 2024
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 72
Est. completion date July 2026
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Immunotherapy
immunotherapy

Locations
Country Name City State
United States University of New Mexico Comprehensive Cancer Center Albuquerque New Mexico
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Monument Health Cancer Care Institute Rapid City South Dakota
United States Huntsman Cancer Institute at the University of Utah Salt Lake City Utah
United States Avera Cancer Institute Sioux Falls South Dakota
United States Arizona Cancer Center at the Unvieristy of Arizona Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Tumor mutational burden Describe the differences in tumor mutational burden (TMB) between the American Indian population vs Whites or Black Americans 1 year
Other Somatic genetic variants Describe the somatic genetic variants differences between the American Indian population vs Whites or Black Americans 1 year
Other Demographic differences Describe the demographics differences between the American Indian population vs Whites or Black Americans 1 year
Primary Progression Free Survival Evaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy 1 year
Primary Overall Survival Benefit Evaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy 1 year
Primary Treatment related Adverse Events Evaluating treatment related adverse events of American Indian population vs. white population who were treated with immunotherapy 1 year
Secondary Difference in cancer related mortality Evaluate the difference in cancer related mortality in American Indian populations vs white 1 year
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