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Trial Title: Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

NCT ID: NCT05863052

Condition: Immune Checkpoint Inhibitors
Metastatic Solid Tumor
Nonsmall Cell Lung Cancer
Melanoma
Renal Cell Carcinoma
Gastrointestinal Cancer
Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Gastrointestinal Neoplasms
Carcinoma, Non-Small-Cell Lung
Immunomodulating Agents

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Biological
Intervention name: Immunotherapy
Description: immunotherapy
Arm group label: American Indian population
Arm group label: Caucasians treated with immunotherapy

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.

Criteria for eligibility:

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

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Arizona Cancer Center at the Unvieristy of Arizona

Address:
City: Tucson
Zip: 85719
Country: United States

Facility:
Name: University of New Mexico Comprehensive Cancer Center

Address:
City: Albuquerque
Zip: 87102
Country: United States

Facility:
Name: Stephenson Cancer Center

Address:
City: Oklahoma City
Zip: 73117
Country: United States

Facility:
Name: Monument Health Cancer Care Institute

Address:
City: Rapid City
Zip: 57701
Country: United States

Facility:
Name: Avera Cancer Institute

Address:
City: Sioux Falls
Zip: 57105
Country: United States

Facility:
Name: Huntsman Cancer Institute at the University of Utah

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Start date: January 31, 2022

Completion date: December 2026

Lead sponsor:
Agency: University of Oklahoma
Agency class: Other

Source: University of Oklahoma

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05863052

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