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临床试验/NCT06647134
NCT06647134招募中不适用

A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Safety and Adverse Events (AEs).

研究概览

简要总结

To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.

详细描述

  1. To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
  2. To explore domains relevant to participants experiencing rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, and attitudes to domains identified from the literature

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • The criteria are:
  • Patients aged 18 years and above
  • English (conversational level) speaking, with the ability to give informed consent
  • Patients with a rheumatologist clinician diagnosis of inflammatory arthritis irAE or PMR irAE following ICI therapy

排除标准

  • Acutely life-threatening or worsening cancer
  • Hearing impairment functionally limiting participation in verbal interview

结局指标

主要结局

Safety and Adverse Events (AEs).

时间窗: Through study completion; an average of 1 year

Incidence of Adverse Events

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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