在 GUSTO 临床试验中验证膀胱癌的分子亚型

IF 3.4 2区 医学 Q1 PATHOLOGY
Jon Griffin, Jenny Down, Lewis A Quayle, Paul R Heath, Ewan A Gibb, Elai Davicioni, Yang Liu, Xin Zhao, Jayne Swain, Dennis Wang, Syed Hussain, Simon Crabb, James WF Catto, the GUSTO Trial Management Group
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引用次数: 0

摘要

GUSTO临床试验(尿路上皮癌基因表达亚型:分层治疗和肿瘤学结果)利用分子亚型指导肌层浸润性膀胱癌(MIBC)患者的新辅助疗法。在开始 GUSTO 试验之前,我们需要确定一个商业亚型分析平台(Decipher Bladder; Veracyte)在外部试验实验室进行分析时的可靠性,因为以前从未进行过这样的分析。在此,我们报告了利用基因表达谱分析对 TCGA 分子亚型模型进行试验前验证的结果。采用基因表达芯片对福尔马林固定石蜡包埋的 MIBC 组织块进行基因表达亚型分析。评估了实验室内部和实验室之间的技术重现性,以及实验室和生物信息学过程的质量控制。对 18 个样本进行了分析。所有样本都成功提取了足够质量和数量的 RNA。所有亚型在样本群中均有体现。每个样本都在我们的实验室和另一个参考实验室进行了两次亚型分析。在实验室内部或实验室之间的重复中,亚型没有出现临床上明显的不一致。样本组织病理学检查显示,亚型内部和亚型之间的形态学表现存在差异。总之,这些结果表明,通过基因表达谱进行分子亚型分析具有可重复性和稳健性,适合用于 GUSTO 临床试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Verification of molecular subtyping of bladder cancer in the GUSTO clinical trial

Verification of molecular subtyping of bladder cancer in the GUSTO clinical trial

The GUSTO clinical trial (Gene expression subtypes of Urothelial carcinoma: Stratified Treatment and Oncological outcomes) uses molecular subtypes to guide neoadjuvant therapies in participants with muscle-invasive bladder cancer (MIBC). Before commencing the GUSTO trial, we needed to determine the reliability of a commercial subtyping platform (Decipher Bladder; Veracyte) when performed in an external trial laboratory as this has not been done previously. Here, we report our pre-trial verification of the TCGA molecular subtyping model using gene expression profiling. Formalin-fixed paraffin-embedded tissue blocks of MIBC were used for gene expression subtyping by gene expression microarrays. Intra- and inter-laboratory technical reproducibilities, together with quality control of laboratory and bioinformatics processes, were assessed. Eighteen samples underwent analysis. RNA of sufficient quality and quantity was successfully extracted from all samples. All subtypes were represented in the cohort. Each sample was subtyped twice in our laboratory and once in a separate reference laboratory. No clinically significant discordance in subtype occurred between intra- or inter-laboratory replicates. Examination of sample histopathology showed variability of morphological appearances within and between subtypes. Overall, these results show that molecular subtyping by gene expression profiling is reproducible, robust and suitable for use in the GUSTO clinical trial.

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来源期刊
Journal of Pathology Clinical Research
Journal of Pathology Clinical Research Medicine-Pathology and Forensic Medicine
CiteScore
7.40
自引率
2.40%
发文量
47
审稿时长
20 weeks
期刊介绍: The Journal of Pathology: Clinical Research and The Journal of Pathology serve as translational bridges between basic biomedical science and clinical medicine with particular emphasis on, but not restricted to, tissue based studies. The focus of The Journal of Pathology: Clinical Research is the publication of studies that illuminate the clinical relevance of research in the broad area of the study of disease. Appropriately powered and validated studies with novel diagnostic, prognostic and predictive significance, and biomarker discover and validation, will be welcomed. Studies with a predominantly mechanistic basis will be more appropriate for the companion Journal of Pathology.
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