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临床试验/NCT05863052
NCT05863052进行中(未招募)不适用

Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population Treated With Immune Checkpoint Inhibitors for Various Cancers

University of Oklahoma6 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年1月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
72
试验地点
6
主要终点
Progression Free Survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • patients who did not receive immune checkpoint inhibitor therapy

研究组 & 干预措施

American Indian population

干预措施: Immunotherapy (Biological)

Caucasians treated with immunotherapy

干预措施: Immunotherapy (Biological)

结局指标

主要结局

Progression Free Survival

时间窗: 1 year

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

Overall Survival Benefit

时间窗: 1 year

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

Treatment related Adverse Events

时间窗: 1 year

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

次要结局

  • Difference in cancer related mortality(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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