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The evidence base for circulating tumour DNA blood-based biomarkers for the early detection of cancer: a systematic mapping review

机译:循环肿瘤DNa血液生物标志物用于癌症早期检测的证据基础:系统的绘图评价

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摘要

Background: The presence of circulating cell-free DNA from tumours in blood (ctDNA) is of major importance toudthose interested in early cancer detection, as well as to those wishing to monitor tumour progression or diagnoseudthe presence of activating mutations to guide treatment. In 2014, the UK Early Cancer Detection Consortiumudundertook a systematic mapping review of the literature to identify blood-based biomarkers with potential for theuddevelopment of a non-invasive blood test for cancer screening, and which identified this as a major area of interest.udThis review builds on the mapping review to expand the ctDNA dataset to examine the best options for theuddetection of multiple cancer types.udMethods: The original mapping review was based on comprehensive searches of the electronic databases Medline,udEmbase, CINAHL, the Cochrane library, and Biosis to obtain relevant literature on blood-based biomarkers for canceruddetection in humans (PROSPERO no. CRD42014010827). The abstracts for each paper were reviewed to determineudwhether validation data were reported, and then examined in full. Publications concentrating on monitoring ofuddisease burden or mutations were excluded.udResults: The search identified 94 ctDNA studies meeting the criteria for review. All but 5 studies examined oneudcancer type, with breast, colorectal and lung cancers representing 60% of studies. The size and design of theudstudies varied widely. Controls were included in 77% of publications. The largest study included 640 patients, butudthe median study size was 65 cases and 35 controls, and the bulk of studies (71%) included less than 100 patients.udStudies either estimated cfDNA levels non-specifically or tested for cancer-specific mutations or methylationudchanges (the majority using PCR-based methods).udConclusion: We have systematically reviewed ctDNA blood biomarkers for the early detection of cancer. Preanalytical,udanalytical, and post-analytical considerations were identified which need to be addressed before suchudbiomarkers enter clinical practice. The value of small studies with no comparison between methods, or even theudinclusion of controls is highly questionable, and larger validation studies will be required before such methods canudbe considered for early cancer detection.ud
机译:背景:血液中循环肿瘤的无细胞DNA(ctDNA)的存在对于对早期癌症检测有兴趣的人,以及希望监测肿瘤进展或诊断存在激活突变以指导指导的人来说至关重要。治疗。 2014年,英国早期癌症检测协会对文献进行了系统的制图综述,以鉴定具有潜在发展潜力的基于血液的生物标志物,以开发用于癌症筛查的非侵入性血液检测,并将其确定为主要的研究领域。兴趣。 ud此评价建立在作图评价的基础上,扩展了ctDNA数据集,以检查多种癌症类型的 uddetect的最佳选择。 ud方法:原始的作图评价是基于对电子数据库Medline, udEmbase, CINAHL,Cochrane库和Biosis,以获取有关人类癌症/未检测到的基于血液的生物标记物的相关文献(PROSPERO号CRD42014010827)。审查每篇论文的摘要以确定是否报告了验证数据,然后进行全面检查。排除了专注于监测疾病负担或突变的出版物。 ud结果:该搜索确定了94份符合审查标准的ctDNA研究。除5项研究外,所有研究均检查了一种癌症类型,其中乳腺癌,结直肠癌和肺癌占研究的60%。研究的规模和设计差异很大。控件包含在77%的出版物中。最大的研究包括640名患者,但是中位研究规模为65例和35名对照,并且大部分研究(71%)包括不到100名患者。 ud研究要么非特异性地估计cfDNA水平,要么测试了癌症特异性突变或甲基化改变(大多数使用基于PCR的方法)。 ud结论:我们已经系统地复查了ctDNA血液生物标记物,以用于癌症的早期检测。确定了分析前,分析后和分析后的注意事项,这些注意事项在此类生物标志物进入临床实践之前必须加以解决。在没有方法之间比较的情况下进行小型研究的价值,甚至根本没有对照,这是高度可疑的,在考虑将此类方法用于早期癌症检测之前,将需要进行较大的验证研究。

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