Clinical trial NCT05863052: Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population
Official title: Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population Treated With Immune Checkpoint Inhibitors for Various Cancers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Immune Checkpoint Inhibitors
Metastatic Solid Tumor
Nonsmall Cell Lung Cancer
Melanoma
Renal Cell Carcinoma
Gastrointestinal Cancer
Squamous Cell Carcinoma
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: American Indian population is the primary group of interest for this study.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
measure: Overall Survival Benefit
timeFrame: 1 year
measure: Treatment related Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: Difference in cancer related mortality
timeFrame: 1 year
Other outcomes:
measure: Tumor mutational burden
timeFrame: 1 year
measure: Somatic genetic variants
timeFrame: 1 year
measure: Demographic differences
timeFrame: 1 year
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at the Unvieristy of Arizona
state: Arizona
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Rapid City
country: United States
facility: Monument Health Cancer Care Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
Study officials:
affiliation: University of Oklahoma
name: Abdul Naqash, MD
role: PRINCIPAL_INVESTIGATOR
References: