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Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

University of Oklahoma (OU) logo

University of Oklahoma (OU)

Status

Active, not recruiting

Conditions

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

Treatments

Biological: Immunotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT05863052
OU202111ARN-OKAMERICANINDIAN (Other Identifier)
OU-SCC-ClinO+GenD
BAA PMWP 213 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

American Indian population
Treatment:
Biological: Immunotherapy
Caucasians treated with immunotherapy
Treatment:
Biological: Immunotherapy

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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