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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