免疫疗法的副作用的性别差异:优化癌症治疗的可能线索 (G-DEFINER):观察性前性多中心研究的研究协议
Rosalba Miceli1, Hanna Eriksson2, Giuseppe Lo Russo3
1Unit of Biostatistics for Clinical Research, Department of Epidemiology and Data Science, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. rosalba.miceli@istitutotumori.mi.it.
本研究调查了接受免疫检查点抑制剂 (ICI) 的患者的免疫相关不良事件 (irAEs),比较性别之间的发病率并探索性别特异性因素. 这些发现旨在加强个性化癌症治疗策略,并改善irAE诊断.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 临床试验 临床试验
背景情况:
- 免疫检查点抑制剂 (ICI) 已经彻底改变了癌症治疗,但与免疫相关的不良事件 (irAEs) 有关.
- 有限的数据存在于性和性别差异的irAE发生及其潜在因素.
研究的目的:
- 为了比较女性与接受ICI治疗的男性患者中IRE的发病率.
- 在绝经前和绝经后的女性中,以及在各种临床和性别相关因素中调查irAEs.
- 探索与irAEs相关的荷尔蒙,基因表达,SNP,细胞因子和肠道微生物群的个人资料.
主要方法:
- 在G-DEFINER研究中,从多个国际癌症中心招募了患者.
- 患者招募受到COVID-19大流行的影响,招募了250名患者,而计划招募400名患者.
- 临床和翻译数据正在进行分析.
主要成果:
- 数据收集和分析正在进行中.
- 这项研究旨在提供关于irAEs的全面临床和转化数据.
结论:
- 预期的结果包括通过个性化方法改善ICI治疗的癌症患者的管理.
- 该研究预计可以在现实临床环境中提升irAEs的及时诊断和管理.
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