Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

NCT ID: NCT05863052

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-31

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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American Indian population

Immunotherapy

Intervention Type BIOLOGICAL

immunotherapy

Caucasians treated with immunotherapy

Immunotherapy

Intervention Type BIOLOGICAL

immunotherapy

Interventions

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Immunotherapy

immunotherapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abdul Naqash, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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Arizona Cancer Center at the Unvieristy of Arizona

Tucson, Arizona, United States

Site Status

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Site Status

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Monument Health Cancer Care Institute

Rapid City, South Dakota, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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BAA PMWP 213

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OU202111ARN-OKAMERICANINDIAN

Identifier Type: OTHER

Identifier Source: secondary_id

OU-SCC-ClinO+GenD

Identifier Type: -

Identifier Source: org_study_id

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