Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

• Sponsor: University of Oklahoma (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05863052
• Collaborator: (none)
• Enrollment: 72
• Locations: 6
• Anticipated Duration (Months): 47
• Patients Per Site: 12
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Checkpoint Inhibitors; Metastatic Solid Tumor; Nonsmall Cell Lung Cancer; Melanoma; Renal Cell Carcinoma; Gastrointestinal Cancer; Squamous Cell Carcinoma	Biological: Immunotherapy

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 72 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population Treated With Immune Checkpoint Inhibitors for Various Cancers
• Actual Study Start Date: Jan 31, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
American Indian population	Biological: Immunotherapy; immunotherapy
Caucasians treated with immunotherapy	Biological: Immunotherapy; immunotherapy

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [1 year]

   Evaluating progression free survival of American Indian population vs. White population who were treated with immunotherapy

2. Overall Survival Benefit [1 year]

   Evaluating the overall survival benefit of American Indian population vs. white population who were treated with immunotherapy

3. Treatment related Adverse Events [1 year]

   Evaluating treatment related adverse events of American Indian population vs. white population who were treated with immunotherapy

Secondary Outcome Measures

1. Difference in cancer related mortality [1 year]

   Evaluate the difference in cancer related mortality in American Indian populations vs white

Other Outcome Measures

1. Tumor mutational burden [1 year]

   Describe the differences in tumor mutational burden (TMB) between the American Indian population vs Whites or Black Americans

2. Somatic genetic variants [1 year]

   Describe the somatic genetic variants differences between the American Indian population vs Whites or Black Americans

3. Demographic differences [1 year]

   Describe the demographics differences between the American Indian population vs Whites or Black Americans

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center at the Unvieristy of Arizona	Tucson	Arizona	United States	85719
2	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico	United States	87102
3	Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73117
4	Monument Health Cancer Care Institute	Rapid City	South Dakota	United States	57701
5	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
6	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Oklahoma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT05863052
• Other Study ID Numbers: OU-SCC-ClinO+GenD
• First Posted: May 17, 2023
• Last Update Posted: May 17, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell; Gastrointestinal Neoplasms; Carcinoma, Non-Small-Cell Lung; Immunomodulating Agents

Study Results

No Results Posted as of May 17, 2023