NCT05863052

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jan 2022Dec 2027

Study Start

First participant enrolled

January 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

March 13, 2023

Last Update Submit

February 5, 2026

Conditions

Renal Cell CarcinomaGastrointestinal CancerSquamous Cell CarcinomaImmune Checkpoint InhibitorsMetastatic Solid TumorNonsmall Cell Lung CancerMelanoma

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Difference in cancer related mortality

    1 year

Other Outcomes (3)

  • Tumor mutational burden

    1 year

  • Somatic genetic variants

    1 year

  • Demographic differences

    1 year

Study Arms (2)

American Indian population

Biological: Immunotherapy

Caucasians treated with immunotherapy

Biological: Immunotherapy

Interventions

ImmunotherapyBIOLOGICAL

immunotherapy

American Indian populationCaucasians treated with immunotherapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

American Indian population is the primary group of interest for this study.

You may qualify if:

  • 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

You may not qualify if:

  • patients who did not receive immune checkpoint inhibitor therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Arizona Cancer Center at the Unvieristy of Arizona

Tucson, Arizona, 85719, United States

Location

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location

Monument Health Cancer Care Institute

Rapid City, South Dakota, 57701, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasm MetastasisCarcinoma, Non-Small-Cell LungMelanomaCarcinoma, Renal CellGastrointestinal NeoplasmsCarcinoma, Squamous Cell

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Abdul Naqash, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

May 17, 2023

Study Start

January 31, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(6)