Immune Checkpoint InhibitorsNCT05863052
Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population
An observational study of Immune Checkpoint Inhibitors and Metastatic Solid Tumor, run by University of Oklahoma at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Immune Checkpoint Inhibitors, Metastatic Solid Tumor, Nonsmall Cell Lung Cancer
- What is being tested?
- Immunotherapy
- How many people
- 72 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Jan 2022to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: American Indian population is the primary group of interest for this study.
Who may be able to join
- 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
Who cannot join
- patients who did not receive immune checkpoint inhibitor therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Monument Health Cancer Care Institute
Rapid City, South Dakota, 57701
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Arizona Cancer Center at the Unvieristy of Arizona
Tucson, Arizona, 85719
About this study
Official title: Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population Treated With Immune Checkpoint Inhibitors for Various Cancers
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.
Read the 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.
- Conditions
- Immune Checkpoint Inhibitors, Metastatic Solid Tumor, Nonsmall Cell Lung Cancer, Melanoma, Renal Cell Carcinoma, Gastrointestinal Cancer
- Being tested
- Immunotherapy
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Melanoma, Carcinoma, Renal Cell, Gastrointestinal Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyBiological
immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| American Indian population | Not described Receives: Biological: Immunotherapy | |
| Caucasians treated with immunotherapy | Not described Receives: Biological: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Evaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy
Measured: 1 year
Overall Survival Benefit
Evaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy
Measured: 1 year
Treatment related Adverse Events
Evaluating treatment related adverse events of American Indian population vs. white population who were treated with immunotherapy
Measured: 1 year
Secondary outcomes (1)
Difference in cancer related mortality
Evaluate the difference in cancer related mortality in American Indian populations vs white
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start31 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint InhibitorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Naqash, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863052
- Sponsor's protocol ID
- OU-SCC-ClinO+GenD
- Other IDs
- BAA PMWP 213, OU202111ARN-OKAMERICANINDIAN
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No