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从接受 NGS 检测的肿瘤患者的精准临床试验匹配中获得的经验。

Learnings From Precision Clinical Trial Matching for Oncology Patients Who Received NGS Testing.

机构信息

Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN.

Vanderbilt-Ingram Cancer Center, Clinical Trial Shared Resource, Vanderbilt University Medical Center, Nashville, TN.

出版信息

JCO Clin Cancer Inform. 2021 Feb;5:231-238. doi: 10.1200/CCI.20.00142.

Abstract

PURPOSE

Tumor next-generation sequencing reports typically generate trial recommendations for patients based on their diagnosis and genomic profile. However, these require additional refinement and prescreening, which can add to physician burden. We wanted to use human prescreening efforts to efficiently refine these trial options and also elucidate the high-value parameters that have a major impact on efficient trial matching.

METHODS

Clinical trial recommendations were generated based on diagnosis and biomarker criteria using an informatics platform and were further refined by manual prescreening. The refined results were then compared with the initial trial recommendations and the reasons for false-positive matches were evaluated.

RESULTS

Manual prescreening significantly reduced the number of false positives from the informatics generated trial recommendations, as expected. We found that trial-specific criteria, especially recruiting status for individual trial arms, were a high value parameter and led to the largest number of automated false-positive matches.

CONCLUSION

Reflex clinical trial matching approaches that refine trial recommendations based on the clinical details as well as trial-specific criteria have the potential to help alleviate physician burden for selecting the most appropriate trial for their patient. Investing in publicly available resources that capture the recruiting status of a trial at the cohort or arm level would, therefore, allow us to make meaningful contributions to increase the clinical trial enrollments by eliminating false positives.

摘要

目的

肿瘤下一代测序报告通常根据患者的诊断和基因组特征为其生成试验推荐。然而,这些推荐需要进一步的细化和预筛选,这可能会增加医生的负担。我们希望利用人工筛选来有效地细化这些试验选项,并阐明对高效试验匹配有重大影响的高价值参数。

方法

使用信息学平台根据诊断和生物标志物标准生成临床试验推荐,然后通过手动预筛选进行进一步细化。然后将细化的结果与初始试验推荐进行比较,并评估假阳性匹配的原因。

结果

正如预期的那样,手动预筛选显著减少了信息学生成的试验推荐中的假阳性数量。我们发现,试验特异性标准,特别是个体试验臂的招募状态,是一个高价值参数,导致了最多的自动化假阳性匹配。

结论

基于临床细节和试验特异性标准来细化试验推荐的反射式临床试验匹配方法有可能帮助减轻医生为患者选择最合适试验的负担。因此,投资于可公开获取的资源,以队列或臂级别的方式捕获试验的招募状态,将消除假阳性,从而为增加临床试验入组做出有意义的贡献。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bb9/8140789/88b09c41f973/cci-5-cci.20.00142-g001.jpg

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