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| ID | Type | Description | Link |
|---|---|---|---|
| BAA PMWP 213 | Other Grant/Funding Number | FDA | |
| OU202111ARN-OKAMERICANINDIAN | Other Identifier | OUHSC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| American Indian population |
| ||
| Caucasians treated with immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Biological | immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Evaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy | 1 year |
| Overall Survival Benefit | Evaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy | 1 year |
| Treatment related Adverse Events | Evaluating treatment related adverse events of American Indian population vs. white population who were treated with immunotherapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in cancer related mortality | Evaluate the difference in cancer related mortality in American Indian populations vs white | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor mutational burden | Describe the differences in tumor mutational burden (TMB) between the American Indian population vs Whites or Black Americans | 1 year |
| Somatic genetic variants | Describe the somatic genetic variants differences between the American Indian population vs Whites or Black Americans |
Inclusion Criteria:
Exclusion Criteria:
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American Indian population is the primary group of interest for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Abdul Naqash, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center at the Unvieristy of Arizona | Tucson | Arizona | 85719 | United States | ||
| University of New Mexico Comprehensive Cancer Center |
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| 1 year |
| Demographic differences | Describe the demographics differences between the American Indian population vs Whites or Black Americans | 1 year |
| Albuquerque |
| New Mexico |
| 87102 |
| United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73117 | United States |
| Monument Health Cancer Care Institute | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| D005770 | Gastrointestinal Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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