A pilot clinical study to evaluate feasibility of using single patient classifier as a prognostic test in stage II-III gastric cancer patients.

IF 7 2区 医学 Q1 ONCOLOGY
Ji Yeong An, Sung Eun Oh, Soomin Ahn, Hyoung-Ii Kim, Yoo Min Kim, Minah Cho, Keun Won Ryu, Hong Man Yoon, Young Kyu Park, In Gyu Kwon, Sung Hoon Noh, Kyung Hee Lee, In Cho, Myoung Won Son, Jong Won Kim, Young-Woo Kim
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引用次数: 0

Abstract

Objective: Precision medicine approaches emphasize the importance of reliable prognostic tools for guiding individualized therapy decisions. In this study, we evaluated the clinical feasibility of the single patient classifier (SPC) test, a new clinical-grade prognostic assay, in stage II-III gastric cancer patients.

Methods: A prospective multicenter study was conducted, involving 237 patients who underwent gastrectomy between September 2019 and August 2020 across nine hospitals. The SPC test was employed to stratify patients into risk groups, and its feasibility and performance were evaluated. The primary endpoint was the proportion of the cases in which the test results were timely delivered before selecting postoperative treatment. Furthermore, 3-year disease-free survivals of risk groups were analyzed.

Results: The SPC test met the primary endpoint criteria. The 99.5% of SPC tests were timely delivered to hospitals before the postoperative treatment started. In a clinical setting, the median time from the specimen transfer to laboratory to the result delivery to hospital was 4 d. Furthermore, 3-year disease-free survivals were significantly different between risk groups classified with SPC tests.

Conclusions: This study highlights the SPC test's feasibility in offering crucial information timely delivered for making informed decisions regarding postoperative treatment strategies. It also provides evidence to support the implementation of a future prospective clinical trial aimed at evaluating the clinical utility of the SPC test in guiding personalized treatment decisions for gastric cancer patients.

一项试点临床研究,评估将单个患者分类器用作 II-III 期胃癌患者预后检测的可行性。
目的:精准医疗方法强调可靠的预后工具对于指导个体化治疗决策的重要性。在这项研究中,我们评估了单个患者分类器(SPC)测试的临床可行性,这是一种新的临床级预后检测方法,适用于II-III期胃癌患者:开展了一项前瞻性多中心研究,涉及9家医院在2019年9月至2020年8月期间接受胃切除术的237名患者。采用 SPC 检验对患者进行风险分层,并评估其可行性和性能。主要终点是在选择术后治疗前及时得到检测结果的病例比例。此外,还对风险组的 3 年无病生存率进行了分析:结果:SPC检测符合主要终点标准。99.5%的 SPC 检测结果在术后治疗开始前及时送达医院。在临床环境中,从标本转移到实验室到结果送达医院的中位时间为4 d。此外,通过SPC检验划分的风险组别之间的3年无病生存率有显著差异:本研究强调了 SPC 检验的可行性,它能及时提供关键信息,以便就术后治疗策略做出明智的决定。该研究还为未来开展前瞻性临床试验提供了证据支持,该试验旨在评估 SPC 检验在指导胃癌患者个性化治疗决策方面的临床实用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
自引率
9.80%
发文量
1726
审稿时长
4.5 months
期刊介绍: Chinese Journal of Cancer Research (CJCR; Print ISSN: 1000-9604; Online ISSN:1993-0631) is published by AME Publishing Company in association with Chinese Anti-Cancer Association.It was launched in March 1995 as a quarterly publication and is now published bi-monthly since February 2013. CJCR is published bi-monthly in English, and is an international journal devoted to the life sciences and medical sciences. It publishes peer-reviewed original articles of basic investigations and clinical observations, reviews and brief communications providing a forum for the recent experimental and clinical advances in cancer research. This journal is indexed in Science Citation Index Expanded (SCIE), PubMed/PubMed Central (PMC), Scopus, SciSearch, Chemistry Abstracts (CA), the Excerpta Medica/EMBASE, Chinainfo, CNKI, CSCI, etc.
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